Trial Outcomes & Findings for A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors (NCT NCT05070247)
NCT ID: NCT05070247
Last Updated: 2026-01-22
Results Overview
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Up to approximately 32.8 months
Results posted on
2026-01-22
Participant Flow
Participants took part in the study at sites in the United States from 14 April 2022 to 06 January 2025.
Participants with the specified pathologically confirmed locally advanced or metastatic solid tumors, whose disease had progressed on or is intolerant to all standard therapy were enrolled in the study. The study was terminated before initiation of Dose Expansion Phase.
Participant milestones
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
Participants received TAK-500, 8 micrograms per kilogram (µg/kg), intravenous (IV) infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
Participants received premedication with 8 milligrams per kilogram (mg/kg) (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Dose Expansion: TAK-500
Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
3
|
3
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7
|
3
|
2
|
6
|
4
|
5
|
5
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7
|
5
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0
|
|
Overall Study
Response-evaluable Analysis Set
|
3
|
2
|
4
|
2
|
3
|
4
|
3
|
0
|
6
|
2
|
4
|
4
|
5
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
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1
|
3
|
1
|
2
|
0
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
2
|
0
|
6
|
1
|
2
|
5
|
3
|
4
|
4
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6
|
4
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0
|
Reasons for withdrawal
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
Participants received TAK-500, 8 micrograms per kilogram (µg/kg), intravenous (IV) infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
Participants received premedication with 8 milligrams per kilogram (mg/kg) (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Dose Expansion: TAK-500
Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
1
|
1
|
0
|
2
|
0
|
0
|
2
|
1
|
2
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
0
|
4
|
0
|
1
|
2
|
1
|
0
|
0
|
3
|
4
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
2
|
2
|
2
|
0
|
0
|
Baseline Characteristics
A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=7 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 6.11 • n=270 Participants
|
63.0 years
STANDARD_DEVIATION 11.53 • n=4 Participants
|
70.6 years
STANDARD_DEVIATION 5.81 • n=9 Participants
|
57.3 years
STANDARD_DEVIATION 11.68 • n=220 Participants
|
57.0 years
STANDARD_DEVIATION 8.89 • n=3 Participants
|
64.1 years
STANDARD_DEVIATION 7.69 • n=18 Participants
|
62.3 years
STANDARD_DEVIATION 5.77 • n=2259 Participants
|
62.0 years
STANDARD_DEVIATION 2.83 • n=4 Participants
|
52.0 years
STANDARD_DEVIATION 7.48 • n=1 Participants
|
63.8 years
STANDARD_DEVIATION 9.25 • n=3 Participants
|
56.2 years
STANDARD_DEVIATION 17.27 • n=195 Participants
|
66.0 years
STANDARD_DEVIATION 6.04 • n=1 Participants
|
68.9 years
STANDARD_DEVIATION 5.84 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 9.03 • n=1 Participants
|
61.8 years
STANDARD_DEVIATION 9.95 • n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
3 Participants
n=1 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=1 Participants
|
21 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=18 Participants
|
2 Participants
n=2259 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=195 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=1 Participants
|
40 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=195 Participants
|
3 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
12 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=1 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=195 Participants
|
2 Participants
n=1 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=1 Participants
|
49 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=195 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=195 Participants
|
4 Participants
n=1 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=1 Participants
|
46 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
8 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=7 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=7 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 1 (1 cycle = 21 days)Population: The DLT-evaluable analysis set included participants who received all required doses of TAK-500 (with pembrolizumab if in a combination cohort) and remain on study for 21 days from first dosing of TAK-500 (through C1D21) without experiencing a DLT or who have a DLT during the first 21 days after study drug administration.
DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=7 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs)
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=7 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
TEAEs Leading to Dose Modifications
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
TEAEs Leading to Treatment Discontinuations
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)Population: Data at multiple pre-specified Pharmacokinetic (PK) timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)Population: Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)Population: Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)Population: Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)Population: Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)Population: Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)Population: Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 23 days after first administration of TAK-500Population: The tumor biopsy analysis set included participants from the safety population who had baseline and at least 1 postbaseline tumor biopsy sample assessments.
Measurement of changes in tumor immune cell infiltration were measured by immunohistochemistry on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=2 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=2 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=1 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=1 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Changes in Intratumoral Tumor Cell Infiltration
|
—
|
—
|
1.15 cells per square millimeter (cells/mm^2)
Standard Deviation 0.919239
|
0.65 cells per square millimeter (cells/mm^2)
Standard Deviation 0.636396
|
3.23 cells per square millimeter (cells/mm^2)
Standard Deviation 4.389001
|
0.75 cells per square millimeter (cells/mm^2)
Standard Deviation 0.777817
|
—
|
—
|
1.40 cells per square millimeter (cells/mm^2)
Standard Deviation NA
SD was not estimable for a single participant.
|
—
|
3.40 cells per square millimeter (cells/mm^2)
Standard Deviation 3.959798
|
—
|
3.00 cells per square millimeter (cells/mm^2)
Standard Deviation 4.246175
|
0.70 cells per square millimeter (cells/mm^2)
Standard Deviation NA
SD was not estimable for a single participant.
|
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: The immunogenicity analysis set consisted of participants who received at least 1 dose of TAK-500 and had an ADA status assessment at baseline, and at least 1 postbaseline sample. Overall number analyzed is the number of participants with data available for analyses.
Number of participants with positive ADA at any scheduled post-baseline visit are reported.
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=4 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=2 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=2 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Participants With Positive Anti-drug Antibody (ADA) (Acquired Immunogenicity)
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.
ORR is defined as the percentage of participants who achieve cPR or cCR (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per RECIST Version 1.1. CR: defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=4 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=2 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=4 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=2 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=4 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=4 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=2 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Overall Response Rate (ORR)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.
DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (\>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 Participants
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=2 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=4 Participants
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=2 Participants
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=4 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
n=3 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=2 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=4 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=4 Participants
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=5 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=2 Participants
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Disease Control Rate (DCR)
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
0 percentage of participants
95% CI was not estimable as no participant had the event.
|
0 percentage of participants
95% CI was not estimable as no participant had the event.
|
0 percentage of participants
95% CI was not estimable as no participant had the event.
|
0 percentage of participants
95% CI was not estimable as no participant had the event.
|
—
|
0 percentage of participants
95% CI was not estimable as no participant had the event.
|
0 percentage of participants
95% CI was not estimable as no participant had the event.
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: As no participant had a response, there were no evaluable participants for the analyses of this outcome measure.
DOR is defined as the time from the date of first documentation of a cPR or better to the date of first documentation of PD for responders (cPR or better). Responders without documentation of PD will be censored at the date of last response assessment that is SD or better. DOR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: As no participant had a response, there were no evaluable participants for the analyses of this outcome measure.
TTR is defined as the time from the date of first dose administration to the date of first documented cPR or better (determined by the investigator) in the safety population. TTR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
PFS is defined as the time from date of study treatment to the first documented PD based on RECIST v.1.1, or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
OS is defined as the time from the date of first dose administration to the date of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 32.8 monthsPopulation: Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Outcome measures
Outcome data not reported
Adverse Events
Single Agent Dose Escalation: TAK-500 8 µg/kg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Single Agent Dose Escalation: TAK-500 16 µg/kg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
Serious events: 6 serious events
Other events: 7 other events
Deaths: 2 deaths
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 participants at risk
Participants received TAK-500 dose escalation dose starting at 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) TOCI followed by TAK-500 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 participants at risk
Participants received 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 participants at risk
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 16 µg/kg IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX
n=3 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 24 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 24 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 40 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 60 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=7 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
100.0%
3/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
57.1%
4/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
57.1%
4/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
80.0%
4/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Product Issues
Device malfunction
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic embolism
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Single Agent Dose Escalation: TAK-500 8 µg/kg
n=3 participants at risk
Participants received TAK-500 dose escalation dose starting at 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
n=3 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) TOCI followed by TAK-500 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 16 µg/kg
n=5 participants at risk
Participants received 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
n=3 participants at risk
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
n=3 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
n=7 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 16 µg/kg IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX
n=3 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 24 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
n=2 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 24 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
n=6 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 40 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
n=4 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 60 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
n=5 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
n=5 participants at risk
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
n=7 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
n=5 participants at risk
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Acidosis hyperchloraemic
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
57.1%
4/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
100.0%
4/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
75.0%
3/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
57.1%
4/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
100.0%
4/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
100.0%
3/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
100.0%
2/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
4/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
75.0%
3/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
100.0%
5/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
57.1%
4/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diabetic wound
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
75.0%
3/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
100.0%
2/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
100.0%
3/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Infusion site extravasation
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric vein embolism
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Troponin T increased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/2 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place