Trial Outcomes & Findings for A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma (NCT NCT03215030)
NCT ID: NCT03215030
Last Updated: 2026-01-29
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a participants 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 is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
272 participants
Primary outcome timeframe
Up to 54.3 months in Part 1
Results posted on
2026-01-29
Participant Flow
Participants took part in the study at various investigative sites globally from 4 October 2017 to 7 November 2024.
Participants with diagnosis of RRMM were enrolled in this study consisting of Part 1 (Dose Escalation), Part 2 (Dose Expansion), Part 3 (Dose Extension), \& Japan Safety Lead-in to receive modakafusp alfa with/without dexamethasone. 4 participants enrolled in study but discontinued without receiving TAK-573 dosing and are thus not presented below.
Participant milestones
| Measure |
Part 1 (Dose Escalation) Schedule A
Participants received modakafusp alfa 0.001 up to 0.75 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule B
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule C
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 60 mg
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Escalation
STARTED
|
20
|
8
|
7
|
21
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
COMPLETED
|
2
|
1
|
1
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
NOT COMPLETED
|
18
|
7
|
6
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
8
|
3
|
25
|
25
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
4
|
1
|
11
|
16
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
2
|
14
|
9
|
0
|
0
|
0
|
0
|
|
Part 3: Dose Extension
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
75
|
0
|
0
|
|
Part 3: Dose Extension
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
7
|
0
|
0
|
|
Part 3: Dose Extension
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
66
|
68
|
0
|
0
|
|
Japan Safety Lead-In
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Japan Safety Lead-In
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Japan Safety Lead-In
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Part 1 (Dose Escalation) Schedule A
Participants received modakafusp alfa 0.001 up to 0.75 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule B
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule C
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part2(Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 60 mg
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Escalation
Lost to Follow-up
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Death
|
15
|
6
|
6
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Reason Not Specified
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
5
|
2
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
Death
|
0
|
0
|
0
|
0
|
3
|
1
|
5
|
4
|
0
|
0
|
0
|
0
|
|
Part 2: Dose Expansion
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
0
|
0
|
0
|
0
|
|
Part 3: Dose Extension
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part 3: Dose Extension
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
38
|
39
|
0
|
0
|
|
Part 3: Dose Extension
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
7
|
0
|
0
|
|
Part 3: Dose Extension
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
20
|
0
|
0
|
|
Part 3: Dose Extension
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Japan Safety Lead-In
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
Baseline Characteristics
A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Part 1 (Dose Escalation) Schedule A
n=20 Participants
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule B
n=8 Participants
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule C
n=7 Participants
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D
n=21 Participants
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=71 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=75 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 60 mg
n=3 Participants
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 120 mg
n=2 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.56 • n=35 Participants
|
61.1 years
STANDARD_DEVIATION 7.00 • n=4328 Participants
|
60.4 years
STANDARD_DEVIATION 10.47 • n=8687 Participants
|
64.7 years
STANDARD_DEVIATION 10.34 • n=153 Participants
|
61.9 years
STANDARD_DEVIATION 8.63 • n=200 Participants
|
65.7 years
STANDARD_DEVIATION 12.58 • n=12 Participants
|
64.1 years
STANDARD_DEVIATION 12.17 • n=4 Participants
|
70.2 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 9.76 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 9.61 • n=528 Participants
|
66.66 years
STANDARD_DEVIATION 9.71 • n=590 Participants
|
66.00 years
STANDARD_DEVIATION 11.31 • n=32 Participants
|
65.46 years
STANDARD_DEVIATION 9.98 • n=26 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
10 Participants
n=153 Participants
|
1 Participants
n=200 Participants
|
2 Participants
n=12 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
39 Participants
n=528 Participants
|
2 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
125 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
11 Participants
n=153 Participants
|
7 Participants
n=200 Participants
|
1 Participants
n=12 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
36 Participants
n=528 Participants
|
1 Participants
n=590 Participants
|
2 Participants
n=32 Participants
|
143 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
10 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=35 Participants
|
8 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
21 Participants
n=153 Participants
|
8 Participants
n=200 Participants
|
3 Participants
n=12 Participants
|
24 Participants
n=4 Participants
|
23 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
57 Participants
n=528 Participants
|
3 Participants
n=590 Participants
|
2 Participants
n=32 Participants
|
225 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
33 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
1 Participants
n=153 Participants
|
1 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=528 Participants
|
3 Participants
n=590 Participants
|
2 Participants
n=32 Participants
|
23 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
5 Participants
n=153 Participants
|
1 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
34 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
14 Participants
n=153 Participants
|
6 Participants
n=200 Participants
|
3 Participants
n=12 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
51 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
179 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
1 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
11 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=32 Participants
|
32 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
An adverse event (AE) is defined as any untoward medical occurrence in a participants 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 is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)Population: The DLT-evaluable Analysis Set included participants who received all Cycle 1 doses of modakafusp alfa or experienced a DLT in Cycle 1 in the Part 1 Dose Escalation portion of the study.
DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=13 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
|
4 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
An AE is defined as any untoward medical occurrence in a participants 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. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs
|
95 percentage of participants
|
100 percentage of participants
|
85.7 percentage of participants
|
95.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug \& within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1)results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important event. Percentages were rounded off to nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)
|
40 percentage of participants
|
75 percentage of participants
|
28.6 percentage of participants
|
61.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
An AE is defined as any untoward medical occurrence in a participants 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 is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE
|
15 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay
|
30 percentage of participants
|
12.5 percentage of participants
|
57.1 percentage of participants
|
9.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions
|
15 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions
|
10 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: SAS:all participants who took ≥1 dose,even if incomplete,of TAK-573.However,clinically significant laboratory values data were not collected \& will never be available to present due to an issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in the report form,making data collection impossible.This issue did not impact participant safety or reliability of study data,particularly primary endpoint.
Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator's interpretation.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 54.3 months in Part 1Population: SAS:all participants who took ≥1 dose,even if incomplete,of TAK-573.However,clinically significant vital signs measurements data were not collected \& will never be available to present due to an issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in the report form,making data collection impossible.This issue did not impact participant safety or reliability of study data,particularly primary endpoint.
Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 34.7 months in Part 2Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline.
ORR was defined as the percentage of participants who achieved a partial response (PR) rate or better (stringent complete response \[sCR\] + complete response \[CR\] + very good partial response \[VGPR\] + PR) during the study as defined by international myeloma working group (IMWG) uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 36.94
|
0 percentage of participants
Interval 0.0 to 70.76
|
48 percentage of participants
Interval 27.8 to 68.69
|
32 percentage of participants
Interval 14.95 to 53.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Due to early termination, IRC was disbanded prior to completing its evaluation and could not be utilized for the assessment, therefore the data for this outcome measure is not available.
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Scr: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Overall number of participants analyzed is the number of participants with data available for analysis.
Percentage of participants with TEAEs meeting DLT definition were reported. Toxicity was evaluated as per the NCI CTCAE, Version 5.0. The hematologic TEAEs of Grade ≥3 clearly unrelated to the underlying disease and occur during the first cycle that are considered DLTs: Grade ≥3 hemolysis; Grade 4 neutropenia for \>7 consecutive days; Grade 4 thrombocytopenia for \>14 consecutive days; Grade 3 thrombocytopenia with clinically significant bleeding; Any other Grade ≥4 hematologic toxicity except for Grade 4 lymphopenia. An incomplete recovery from treatment-related toxicity causing \>2-week delay in the next scheduled infusion before the initiation of Cycle 2 were considered a DLT. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=20 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=8 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=3 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events
|
10 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
12.5 percentage of participants
|
66.7 percentage of participants
|
24 percentage of participants
|
25 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)Population: The Pharmacokinetic (PK) Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=4 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=4 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=4 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=6 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Cycle 1 Day 1
|
14.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47.6
|
154 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 95.5
|
2980 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29.0
|
11800 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33.5
|
1260 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 106.1
|
2230 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 53.8
|
2460 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38.6
|
15000 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20.0
|
11600 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 30.9
|
15900 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.1
|
|
Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Cycle 1 Day 15
|
16.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 75.4
|
289 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 71.8
|
2750 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18.1
|
11900 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.8
|
1030 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 183.5
|
2600 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37.9
|
—
|
—
|
—
|
—
|
|
Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Cycle 2 Day 1
|
47.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 175.1
|
158 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
3030 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 10.1
|
—
|
—
|
1970 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
2490 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41.5
|
15100 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 2.3
|
9690 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21.3
|
16800 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31.3
|
|
Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Cycle 2 Day 15
|
—
|
—
|
—
|
—
|
1730 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
1270 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=4 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=4 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=4 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=6 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Cycle 1 Day 1
|
4.03 hours
Interval 3.97 to 4.15
|
3.99 hours
Interval 1.95 to 4.25
|
4.40 hours
Interval 3.92 to 6.1
|
4.27 hours
Interval 4.0 to 6.28
|
4.75 hours
Interval 3.97 to 5.6
|
4.03 hours
Interval 4.0 to 4.1
|
4.78 hours
Interval 3.87 to 6.05
|
3.07 hours
Interval 2.07 to 4.07
|
4.94 hours
Interval 4.0 to 6.02
|
4.03 hours
Interval 3.77 to 7.65
|
|
Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Cycle 1 Day 15
|
3.93 hours
Interval 2.02 to 4.05
|
4.02 hours
Interval 3.93 to 4.2
|
4.25 hours
Interval 4.08 to 4.35
|
5.87 hours
Interval 5.78 to 5.95
|
4.28 hours
Interval 4.15 to 6.17
|
4.00 hours
Interval 4.0 to 4.1
|
—
|
—
|
—
|
—
|
|
Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Cycle 2 Day 1
|
2.97 hours
Interval 1.97 to 3.98
|
4.23 hours
Interval 4.23 to 4.23
|
3.98 hours
Interval 3.9 to 4.05
|
—
|
—
|
4.45 hours
Interval 4.45 to 4.45
|
4.00 hours
Interval 3.9 to 5.92
|
3.21 hours
Interval 2.23 to 4.18
|
4.13 hours
Interval 3.9 to 5.95
|
5.52 hours
Interval 3.98 to 7.05
|
|
Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Cycle 2 Day 15
|
—
|
—
|
—
|
—
|
5.65 hours
Interval 5.65 to 5.65
|
4.00 hours
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)Population: PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.Given low exposure at 0.01mg/kg dose,there was insufficient data to characterize terminal phase PK required for calculating this parameter.Consequently,this parameter has been marked as "Not Calculated" and therefore not reported for Part 1,Schedule A,0.01mg/kg dose group,in accordance with non-compartmental PK analysis standards.
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=1 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=2 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=1 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=4 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Cycle 1 Day 1
|
—
|
—
|
14900 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
209000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 83.4
|
—
|
20500 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 33.2
|
14100 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
288000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 44.5
|
199000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 104.4
|
240000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 109.7
|
|
Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Cycle 1 Day 15
|
—
|
2410 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 21.3
|
24000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 38.0
|
286000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 66.5
|
24300 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
20100 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 21.7
|
—
|
—
|
—
|
—
|
|
Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Cycle 2 Day 1
|
—
|
—
|
28000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 49.3
|
—
|
—
|
—
|
73600 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
333000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 54.0
|
243000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 54.5
|
215000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
SECONDARY outcome
Timeframe: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=4 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=4 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=4 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=6 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Cycle 1 Day 15
|
76.3 h*ng/mL
Geometric Coefficient of Variation 34.8
|
1270 h*ng/mL
Geometric Coefficient of Variation 88.4
|
23900 h*ng/mL
Geometric Coefficient of Variation 38.2
|
285000 h*ng/mL
Geometric Coefficient of Variation 66.1
|
8710 h*ng/mL
Geometric Coefficient of Variation 514.0
|
19200 h*ng/mL
Geometric Coefficient of Variation 17.0
|
—
|
—
|
—
|
—
|
|
Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Cycle 2 Day 1
|
128 h*ng/mL
Geometric Coefficient of Variation 113.1
|
584 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
27700 h*ng/mL
Geometric Coefficient of Variation 48.5
|
—
|
—
|
6020 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
15600 h*ng/mL
Geometric Coefficient of Variation 225.4
|
332000 h*ng/mL
Geometric Coefficient of Variation 54.0
|
190000 h*ng/mL
Geometric Coefficient of Variation 77.5
|
582000 h*ng/mL
Geometric Coefficient of Variation 250.5
|
|
Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Cycle 1 Day 1
|
29.5 h*ng/mL
Geometric Coefficient of Variation 19.0
|
550 h*ng/mL
Geometric Coefficient of Variation 111.6
|
30100 h*ng/mL
Geometric Coefficient of Variation 67.9
|
208000 h*ng/mL
Geometric Coefficient of Variation 83.2
|
7090 h*ng/mL
Geometric Coefficient of Variation 263.7
|
10600 h*ng/mL
Geometric Coefficient of Variation 98.0
|
17900 h*ng/mL
Geometric Coefficient of Variation 106.8
|
287000 h*ng/mL
Geometric Coefficient of Variation 44.5
|
197000 h*ng/mL
Geometric Coefficient of Variation 83.9
|
229000 h*ng/mL
Geometric Coefficient of Variation 107.7
|
|
Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Cycle 2 Day 15
|
—
|
—
|
—
|
—
|
22200 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
5090 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)Population: PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=1 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=2 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=1 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=4 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
Cycle 1 Day 1
|
—
|
—
|
0.309 per hour (1/hour)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0933 per hour (1/hour)
Geometric Coefficient of Variation 26.2
|
—
|
0.294 per hour (1/hour)
Geometric Coefficient of Variation 3.1
|
0.265 per hour (1/hour)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0924 per hour (1/hour)
Geometric Coefficient of Variation 0.5
|
0.107 per hour (1/hour)
Geometric Coefficient of Variation 88.7
|
0.113 per hour (1/hour)
Geometric Coefficient of Variation 117.8
|
|
Part 1: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
Cycle 1 Day 15
|
—
|
0.162 per hour (1/hour)
Geometric Coefficient of Variation 4.3
|
0.207 per hour (1/hour)
Geometric Coefficient of Variation 34.6
|
10.0852 per hour (1/hour)
Geometric Coefficient of Variation 20.6
|
0.115 per hour (1/hour)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.179 per hour (1/hour)
Geometric Coefficient of Variation 59.7
|
—
|
—
|
—
|
—
|
|
Part 1: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
Cycle 2 Day 1
|
—
|
—
|
0.197 per hour (1/hour)
Geometric Coefficient of Variation 12.7
|
—
|
—
|
—
|
0.0907 per hour (1/hour)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0528 per hour (1/hour)
Geometric Coefficient of Variation 10.1
|
0.0828 per hour (1/hour)
Geometric Coefficient of Variation 14.6
|
0.0961 per hour (1/hour)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
SECONDARY outcome
Timeframe: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)Population: PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.Given low exposure at 0.01mg/kg dose,there was insufficient data to characterize terminal phase PK required for calculating this parameter.Consequently,this parameter has been marked as "Not Calculated" and therefore not reported for Part 1,Schedule A,0.01mg/kg dose group,in accordance with non-compartmental PK analysis standards.
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=1 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=2 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=1 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=4 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
Cycle 1 Day 15
|
—
|
4.28 hours
Geometric Coefficient of Variation 4.3
|
3.36 hours
Geometric Coefficient of Variation 34.6
|
8.14 hours
Geometric Coefficient of Variation 20.6
|
6.01 hours
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
3.87 hours
Geometric Coefficient of Variation 59.7
|
—
|
—
|
—
|
—
|
|
Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
Cycle 1 Day 1
|
—
|
—
|
2.24 hours
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
7.43 hours
Geometric Coefficient of Variation 26.2
|
—
|
2.36 hours
Geometric Coefficient of Variation 3.1
|
2.61 hours
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
7.50 hours
Geometric Coefficient of Variation 0.4
|
6.51 hours
Geometric Coefficient of Variation 88.6
|
6.16 hours
Geometric Coefficient of Variation 117.7
|
|
Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
Cycle 2 Day 1
|
—
|
—
|
3.52 hours
Geometric Coefficient of Variation 12.8
|
—
|
—
|
—
|
7.64 hours
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
13.1 hours
Geometric Coefficient of Variation 10.1
|
8.37 hours
Geometric Coefficient of Variation 14.6
|
7.22 hours
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
SECONDARY outcome
Timeframe: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)Population: PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.Given low exposure at 0.01mg/kg dose,there was insufficient data to characterize terminal phase PK required for calculating this parameter.Consequently,this parameter has been marked as "Not Calculated" and therefore not reported for Part 1,Schedule A,0.01mg/kg dose group,in accordance with non-compartmental PK analysis standards.
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=1 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=2 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=1 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=4 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: CL: Clearance for Modakafusp Alfa
Cycle 1 Day 1
|
—
|
—
|
0.0268 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.00358 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 83.7
|
—
|
0.0147 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 32.9
|
0.0283 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.00258 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 45.3
|
0.00380 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 102.9
|
0.00628 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 108.4
|
|
Part 1: CL: Clearance for Modakafusp Alfa
Cycle 1 Day 15
|
—
|
0.0415 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 21.3
|
0.0167 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 37.9
|
0.00261 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 66.5
|
0.00820 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0149 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 22.0
|
—
|
—
|
—
|
—
|
|
Part 1: CL: Clearance for Modakafusp Alfa
Cycle 2 Day 1
|
—
|
—
|
0.0143 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 49.2
|
—
|
—
|
—
|
0.00540 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.00226 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 52.1
|
0.00306 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 55.3
|
0.00700 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
SECONDARY outcome
Timeframe: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)Population: PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.Given low exposure at 0.01mg/kg dose,there was insufficient data to characterize terminal phase PK required for calculating this parameter.Consequently,this parameter has been marked as "Not Calculated" and therefore not reported for Part 1,Schedule A,0.01mg/kg dose group,in accordance with non-compartmental PK analysis standards.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)\*MRT, where MRT is mean residence time. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=1 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=2 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=1 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=4 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=3 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
Cycle 2 Day 1
|
—
|
—
|
0.0678 liters/kg
Geometric Coefficient of Variation 31.1
|
—
|
—
|
—
|
0.0640 liters/kg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0456 liters/kg
Geometric Coefficient of Variation 36.9
|
0.0404 liters/kg
Geometric Coefficient of Variation 26.8
|
0.0716 liters/kg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
|
Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
Cycle 1 Day 1
|
—
|
—
|
0.104 liters/kg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0352 liters/kg
Geometric Coefficient of Variation 23.4
|
—
|
0.0575 liters/kg
Geometric Coefficient of Variation 26.4
|
0.117 liters/kg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0329 liters/kg
Geometric Coefficient of Variation 32.1
|
0.0390 liters/kg
Geometric Coefficient of Variation 27.1
|
0.0536 liters/kg
Geometric Coefficient of Variation 24.3
|
|
Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
Cycle 1 Day 15
|
—
|
0.150 liters/kg
Geometric Coefficient of Variation 24.6
|
0.0675 liters/kg
Geometric Coefficient of Variation 36.9
|
0.0319 liters/kg
Geometric Coefficient of Variation 43.3
|
0.0660 liters/kg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for a single participant.
|
0.0624 liters/kg
Geometric Coefficient of Variation 14.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3Population: The Immunogenicity-evaluable Analysis Set included participants from the SAS with a baseline assessment and at least 1 postbaseline immunogenicity assessment. Overall number of participants analyzed is the number of participants with data available for analyses.
ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=17 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=18 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=7 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=3 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=65 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=65 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1, 2 and 3: Percentage of Participants With Positive Anti-drug Antibody (ADA) at Any Scheduled and Unscheduled Post-Baseline Visit
|
41.2 percentage of participants
|
83.3 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
57.1 percentage of participants
|
66.7 percentage of participants
|
61.9 percentage of participants
|
14.3 percentage of participants
|
52.3 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline. Overall number of participants analyzed is the number of participants with data available for analyses.
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=19 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Overall Response Rate (ORR)
|
15.8 percentage of participants
Interval 3.8 to 39.58
|
0 percentage of participants
Interval 0.0 to 36.94
|
0 percentage of participants
Interval 0.0 to 40.96
|
23.8 percentage of participants
Interval 8.22 to 47.17
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline. Overall number of participants analyzed is the number of participants with data available for analysis.
The CBR was defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=19 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=8 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=3 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Clinical Benefit Rate (CBR)
|
15.8 percentage of participants
Interval 3.38 to 39.58
|
0 percentage of participants
Interval 0.0 to 36.94
|
0 percentage of participants
Interval 0.0 to 40.96
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
0 percentage of participants
Interval 0.0 to 36.94
|
0 percentage of participants
Interval 0.0 to 70.76
|
52.0 percentage of participants
Interval 31.31 to 72.2
|
32.0 percentage of participants
Interval 14.95 to 53.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573 and with measurable disease at baseline. Overall number of participants analyzed is the number of participants with data available for analysis.
The DCR was defined as the proportion of participants with a confirmed response of sCR, CR, VGPR, PR, MR, or stable disease (SD) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. SD: no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=19 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=8 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=3 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=25 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Disease Control Rate (DCR)
|
57.9 percentage of participants
Interval 33.5 to 79.75
|
37.5 percentage of participants
Interval 8.52 to 75.51
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
61.9 percentage of participants
Interval 38.44 to 81.89
|
62.5 percentage of participants
Interval 24.49 to 91.48
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
64.0 percentage of participants
Interval 42.52 to 82.03
|
68.0 percentage of participants
Interval 46.5 to 85.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Overall number of participants analyzed is the number of participants with data available for analyses.
DOR was defined as the time from the date of first documentation of response PR or better (sCR + CR + VGPR + PR) to the time of disease progression or death, whichever occurs first. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=6 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=13 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1, 2, and 3: Duration of Response (DOR)
|
2.1 months
Interval 2.0 to 12.0
|
—
|
—
|
7.4 months
Interval 2.8 to 24.8
|
—
|
—
|
24.4 months
Interval 1.0 to 39.7
|
10.3 months
Interval 1.0 to 17.6
|
NA months
Interval 2.07 to 13.57
Median was not reached.
|
9.2 months
Interval 0.76 to 16.82
|
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Overall number of participants analyzed is the number of participants with data available for analyses.
Time to response was defined as the time from first dose to the date of first documentation of response (PR or better \[sCR + CR + VGPR + PR\]) PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=5 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=12 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=8 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Time to Response
|
1.15 months
Interval 1.0 to 3.0
|
—
|
—
|
1.87 months
Interval 0.9 to 3.7
|
—
|
—
|
1.07 months
Interval 0.8 to 5.8
|
1.08 months
Interval 1.0 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analysis.
PFS was defined as the time from the date of enrollment until the date of progressive disease (PD) or death due to any cause, whichever occurs first as defined by IMWG Criteria. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=15 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=7 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=15 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=7 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=2 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=18 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=13 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
n=43 Participants
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
n=44 Participants
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1, 2, and 3: Progression Free Survival (PFS)
|
2.6 months
Interval 0.0 to 13.1
|
1.5 months
Interval 0.2 to 5.4
|
1.4 months
Interval 0.1 to 6.2
|
3.6 months
Interval 0.0 to 26.5
|
1.1 months
Interval 0.5 to 2.3
|
1.4 months
Interval 0.7 to 1.4
|
8.0 months
Interval 0.0 to 40.4
|
3.4 months
Interval 0.0 to 22.7
|
4.1 months
Interval 0.03 to 15.44
|
5.3 months
Interval 0.03 to 19.81
|
SECONDARY outcome
Timeframe: Up to 34.7 months in Part 2; Up to 20.5 months in Part 3Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
The OS was defined as the time from the date of first dose to the date of death due to any cause.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=1 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=18 Participants
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=17 Participants
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 2 and 3: Overall Survival (OS)
|
NA months
Interval 1.5 to 19.9
Median was not reached.
|
NA months
Interval 1.7 to 15.2
Median was not reached.
|
NA months
Interval 0.5 to 22.3
Median was not reached.
|
3.4 months
Interval 1.0 to 3.7
|
NA months
Interval 1.08 to 17.25
Median was not reached.
|
NA months
Interval 0.39 to 19.81
Median was not reached.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Cycle 1 Day 1
|
3540 ng/mL
Geometric Coefficient of Variation 83.7
|
4330 ng/mL
Geometric Coefficient of Variation 23.7
|
32100 ng/mL
Geometric Coefficient of Variation 25.4
|
35700 ng/mL
Geometric Coefficient of Variation 20.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Cycle 2 Day 1
|
3450 ng/mL
Geometric Coefficient of Variation 51.2
|
3870 ng/mL
Geometric Coefficient of Variation 26.6
|
34200 ng/mL
Geometric Coefficient of Variation 24.6
|
36100 ng/mL
Geometric Coefficient of Variation 25.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=19 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Cycle 2 Day 1
|
37200 h*ng/mL
Geometric Coefficient of Variation 35.4
|
43700 h*ng/mL
Geometric Coefficient of Variation 118.5
|
1520000 h*ng/mL
Geometric Coefficient of Variation 60.7
|
2070000 h*ng/mL
Geometric Coefficient of Variation 33.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Cycle 1 Day 1
|
24900 h*ng/mL
Geometric Coefficient of Variation 77.1
|
42700 h*ng/mL
Geometric Coefficient of Variation 19.2
|
1020000 h*ng/mL
Geometric Coefficient of Variation 89.1
|
1280000 h*ng/mL
Geometric Coefficient of Variation 70.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Cycle 1 Day 1
|
40800 h*ng/mL
Geometric Coefficient of Variation 93.6
|
34600 h*ng/mL
Geometric Coefficient of Variation 40.0
|
975000 h*ng/mL
Geometric Coefficient of Variation 90.8
|
1280000 h*ng/mL
Geometric Coefficient of Variation 70.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Cycle 2 Day 1
|
42300 h*ng/mL
Geometric Coefficient of Variation 64.8
|
45600 h*ng/mL
Geometric Coefficient of Variation 74.7
|
1510000 h*ng/mL
Geometric Coefficient of Variation 62.5
|
1650000 h*ng/mL
Geometric Coefficient of Variation 56.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
Cycle 1 Day 1
|
0.114 1/h
Geometric Coefficient of Variation 67.0
|
0.111 1/h
Geometric Coefficient of Variation 31.0
|
0.0478 1/h
Geometric Coefficient of Variation 63.6
|
0.0468 1/h
Geometric Coefficient of Variation 62.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
Cycle 2 Day 1
|
0.127 1/h
Geometric Coefficient of Variation 80.1
|
0.171 1/h
Geometric Coefficient of Variation 64.0
|
0.0381 1/h
Geometric Coefficient of Variation 36.9
|
0.0276 1/h
Geometric Coefficient of Variation 54.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Cycle 1 Day 1
|
5.70 hours
Interval 4.08 to 7.73
|
3.27 hours
Interval 2.6 to 9.0
|
1.18 hours
Interval 0.93 to 3.0
|
1.68 hours
Interval 1.07 to 6.57
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Cycle 2 Day 1
|
5.68 hours
Interval 3.88 to 6.68
|
3.30 hours
Interval 1.12 to 9.0
|
1.29 hours
Interval 0.9 to 4.88
|
1.63 hours
Interval 1.1 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=19 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: CL: Clearance for Modakafusp Alfa
Cycle 1 Day 1
|
0.0160 L/h/kg
Geometric Coefficient of Variation 77.4
|
0.00937 L/h/kg
Geometric Coefficient of Variation 19.0
|
0.00147 L/h/kg
Geometric Coefficient of Variation 89.9
|
0.00119 L/h/kg
Geometric Coefficient of Variation 67.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: CL: Clearance for Modakafusp Alfa
Cycle 2 Day 1
|
0.0107 L/h/kg
Geometric Coefficient of Variation 35.6
|
0.00912 L/h/kg
Geometric Coefficient of Variation 118.7
|
0.000995 L/h/kg
Geometric Coefficient of Variation 61.2
|
0.000737 L/h/kg
Geometric Coefficient of Variation 36.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)\*MRT, where MRT is mean residence time.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=19 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
Cycle 2 Day 1
|
0.0779 L/kg
Geometric Coefficient of Variation 32.2
|
0.0501 L/kg
Geometric Coefficient of Variation 41.8
|
0.0289 L/kg
Geometric Coefficient of Variation 39.6
|
0.0260 L/kg
Geometric Coefficient of Variation 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
Cycle 1 Day 1
|
0.114 L/kg
Geometric Coefficient of Variation 32.8
|
0.0646 L/kg
Geometric Coefficient of Variation 4.7
|
0.0260 L/kg
Geometric Coefficient of Variation 67.6
|
0.0276 L/kg
Geometric Coefficient of Variation 16.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)Population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=3 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=2 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=21 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
Cycle 1 Day 1
|
6.08 hours
Geometric Coefficient of Variation 67.0
|
6.22 hours
Geometric Coefficient of Variation 31.0
|
14.5 hours
Geometric Coefficient of Variation 63.6
|
14.8 hours
Geometric Coefficient of Variation 62.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
Cycle 2 Day 1
|
5.46 hours
Geometric Coefficient of Variation 80.1
|
4.07 hours
Geometric Coefficient of Variation 64.0
|
18.2 hours
Geometric Coefficient of Variation 36.9
|
25.1 hours
Geometric Coefficient of Variation 54.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=71 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=75 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Objective Response Rate (ORR) by Investigator Assessment
|
32.4 percentage of participants
Interval 21.76 to 44.55
|
41.3 percentage of participants
Interval 30.08 to 53.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
The CBR was defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=71 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=75 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator Assessment
|
38.0 percentage of participants
Interval 26.76 to 50.33
|
48.0 percentage of participants
Interval 36.31 to 59.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with events. Participants with no post baseline response assessment were censored.
Duration of clinical benefit was defined as the time from first documented evidence of confirmed MR or better until the earliest date of a confirmed PD per IMWG, or death among participants who achieve a confirmed MR or better. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=27 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=36 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Duration of Clinical Benefit
|
NA months
Interval 6.7 to
Due to early termination and low number of participants with post-baseline assessment, median and upper limit of 95% CI was not reached.
|
9.2 months
Interval 4.99 to
Due to early termination and low number of participants with post-baseline assessment, upper limit of 95% CI was not reached.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
The DCR was defined as the proportion of participants with a confirmed response of sCR, CR, VGPR, PR, MR, or stable disease (SD) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. SD: no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=71 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=75 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment
|
74.6 percentage of participants
Interval 62.92 to 84.23
|
68.0 percentage of participants
Interval 56.22 to 78.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
Duration of disease control was defined as the time from first documented evidence of SD or better until the earliest date of a confirmed PD per IMWG, or death among participants who achieved a SD or better. SD: no known evidence of progressive or new bone lesions if radiographic studies were performed. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=30 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=25 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Duration of Disease Control
|
6.5 months
Interval 0.03 to 14.52
|
5.6 months
Interval 0.03 to 18.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=37 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=39 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Time to Progression (TTP) by IRC and Investigator Assessment
|
4.7 months
Interval 0.03 to 15.44
|
5.5 months
Interval 0.03 to 19.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The Intent-to-Treat (ITT) Analysis Set included all randomized participants regardless of whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed is the number of participants from ITT analysis set who achieved CR.
MRD negativity rate at a sensitivity of 10\^-5 was defined as participants who were MRD negative at a sensitivity of 10\^-5 in participants achieving suspected complete response (CR). CR was defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria was required.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=1 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=1 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The ITT Analysis Set included all randomized participants regardless of whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed is the number of participants from ITT analysis set who achieved CR.
Duration of MRD negativity (10\^-5) was defined as the time from the first MRD negative status (10\^-5) to the earliest date of the MRD positive status (10\^-5), confirmed PD per IMWG or death.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=1 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=1 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
|
NA months
Standard Deviation NA
Due to insufficient number of participants the median of duration of MRD negativity could not be accurately obtained.
|
NA months
Standard Deviation NA
Due to insufficient number of participants the median of duration of MRD negativity could not be accurately obtained.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
An AE is defined as any untoward medical occurrence in a participants 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 is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=71 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=75 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Percentage of Participants With Treatment -Emergent Adverse Events (TEAEs)
|
98.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts.
AE: any untoward medical occurrence in participants administered pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug \& within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event. Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=71 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=75 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs)
|
39.4 percentage of participants
|
44.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: FAS:all participants who took ≥1 dose,even if incomplete,of TAK-573 in Part 3 extension cohorts.However,clinically significant laboratory values data were not collected\&will never be available to present due to issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in report form,making data collection impossible.This issue did not impact participant safety/reliability of study data,particularly primary endpoint.
Laboratory values included hematology, chemistry, and urinalysis as interpreted by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.
ECOG performance status was measured at baseline and over time. ECOG performance status was measured on a 6 point scale: Grade 0: Normal activity, Grade 1: Symptoms but ambulatory, Grade 2: In bed \<50% of the time, Grade 3: In bed \>50% of the time, Grade 4: 100% bedridden, Grade 5: Dead. Reported here is the baseline status and the worst post-baseline status measured. A decrease in grade from baseline indicates an improvement. Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=68 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=63 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 1; Worst Post-baseline: 4
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 0; Worst Post-baseline: 0
|
11 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 0; Worst Post-baseline: 1
|
5 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 0; Worst Post-baseline: 2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 0; Worst Post-baseline: 3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 1; Worst Post-baseline: 0
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 1; Worst Post-baseline: 1
|
31 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 1; Worst Post-baseline: 2
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 1; Worst Post-baseline: 3
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 2; Worst Post-baseline: 2
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 2; Worst Post-baseline: 3
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: 2; Worst Post-baseline: 4
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=71 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=75 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Health Care Utilization: Length of Hospital Stays
|
14 days
Interval 2.0 to 240.0
|
11 days
Interval 1.0 to 158.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: Immunogenicity-Evaluable Set Analysis included participants with a baseline assessment and at least 1 post-baseline immunogenicity assessment. Overall number of participants analyzed is the number of participants with data available for analyses.
Percentages were rounded off to the nearest decimal.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=65 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=65 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Percentage of Participants With Neutralizing Antibodies (NAb) at Any Scheduled and Unscheduled Post-Baseline Visit
|
47.7 percentage of participants
|
44.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.5 months in Part 3Population: The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
Medical encounters included hospitalizations, emergency room stays, or outpatient visits.
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=46 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=57 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter
Hospitalizations
|
29 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter
Emergency Room Stays
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter
All Outpatient Visits
|
10 Participants
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18 Participants
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SECONDARY outcome
Timeframe: Baseline, Cycle 9 Day 8 [cycle length was 28 days] (up to 7.7 months)Population: The PRO Analysis Set included all participants with a baseline and at least one post-baseline measurement of any PRO measure (EORTC QLQ-MY20 or EQ-5D-5L). Overall number of participants analyzed is the number of participants with data available for analyses.
EORTC QLQ-MY20 is a myeloma-specific module developed by the EORTC group specifically to assess quality of life in participants with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items). All transformed scale scores range from 0 to 100 with higher scores indicating worse symptoms (Disease Symptoms and Side Effects of Treatment) or better support/functioning (Future Perspective and Body Image).
Outcome measures
| Measure |
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=7 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=6 Participants
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
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Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
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Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
Side Effects of Treatment
|
4.7 score on a scale
Standard Deviation 11.62
|
7.0 score on a scale
Standard Deviation 5.45
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—
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—
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—
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—
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—
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—
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—
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Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
Disease Symptoms
|
-7.9 score on a scale
Standard Deviation 22.63
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-7.4 score on a scale
Standard Deviation 10.93
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—
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—
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—
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—
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—
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—
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—
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—
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Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
Body Image
|
4.8 score on a scale
Standard Deviation 35.63
|
0.0 score on a scale
Standard Deviation 21.06
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—
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—
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—
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—
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—
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—
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—
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—
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Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
Future Perspective
|
11.1 score on a scale
Standard Deviation 9.06
|
7.4 score on a scale
Standard Deviation 34.92
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—
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—
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—
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—
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—
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—
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—
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Adverse Events
Part 1 (Dose Escalation) Schedule A
Serious events: 8 serious events
Other events: 20 other events
Deaths: 15 deaths
Part 1 (Dose Escalation) Schedule B
Serious events: 6 serious events
Other events: 8 other events
Deaths: 6 deaths
Part 1 (Dose Escalation) Schedule C
Serious events: 2 serious events
Other events: 7 other events
Deaths: 6 deaths
Part 1 (Dose Escalation) Schedule D
Serious events: 13 serious events
Other events: 21 other events
Deaths: 8 deaths
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Serious events: 1 serious events
Other events: 8 other events
Deaths: 3 deaths
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Serious events: 7 serious events
Other events: 24 other events
Deaths: 5 deaths
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Serious events: 9 serious events
Other events: 24 other events
Deaths: 6 deaths
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Serious events: 28 serious events
Other events: 70 other events
Deaths: 19 deaths
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Serious events: 33 serious events
Other events: 74 other events
Deaths: 20 deaths
Japan Lead-in: Modakafusp Alfa 60 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Japan Lead-in: Modakafusp Alfa 120 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 (Dose Escalation) Schedule A
n=20 participants at risk
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule B
n=8 participants at risk
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule C
n=7 participants at risk
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D
n=21 participants at risk
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=8 participants at risk
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=3 participants at risk
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=25 participants at risk
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=25 participants at risk
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=71 participants at risk
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=75 participants at risk
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 60 mg
n=3 participants at risk
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
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Japan Lead-in: Modakafusp Alfa 120 mg
n=2 participants at risk
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.6%
4/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Asthenia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Clostridium difficile infection
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Psychiatric disorders
Delirium
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Device related bacteraemia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Ejection fraction decreased
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Electrophoresis protein abnormal
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Fatigue
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
General physical condition abnormal
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
General physical health deterioration
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Light chain analysis increased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Mucosal inflammation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Pain
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.5%
6/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.3%
7/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Sepsis
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Respiratory syncytial virus infection
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Septic shock
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Stupor
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Sudden death
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.6%
4/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Troponin increased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
Other adverse events
| Measure |
Part 1 (Dose Escalation) Schedule A
n=20 participants at risk
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule B
n=8 participants at risk
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule C
n=7 participants at risk
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 1 (Dose Escalation) Schedule D
n=21 participants at risk
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
n=8 participants at risk
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
n=3 participants at risk
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
n=25 participants at risk
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
n=25 participants at risk
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
n=71 participants at risk
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
n=75 participants at risk
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 60 mg
n=3 participants at risk
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
Japan Lead-in: Modakafusp Alfa 120 mg
n=2 participants at risk
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
5/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.6%
2/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.5%
6/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.7%
11/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
5/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
62.5%
5/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
42.9%
3/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
71.4%
15/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
37.5%
3/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
3/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
56.0%
14/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
44.0%
11/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
43.7%
31/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
42.7%
32/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
1/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
20.0%
5/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
6.7%
5/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
5/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.6%
6/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.7%
11/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Asthenia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
10.7%
8/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
4/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
13.3%
10/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Blood creatinine increased
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Brain fog
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Bronchiolitis
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Chest discomfort
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Chest pain
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Chills
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.6%
6/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
20.0%
5/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
6.7%
5/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Chronic kidney disease-mineral and bone disorder
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.6%
4/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
5/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.6%
2/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.9%
12/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
29.3%
22/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
11.3%
8/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
18.7%
14/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Device related infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
6/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
37.5%
3/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
3/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
24.0%
6/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
21.1%
15/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
17.3%
13/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
10.7%
8/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
20.0%
5/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
20.0%
5/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
18.7%
14/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Ear infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
23.8%
5/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.6%
4/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
6.7%
5/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Fatigue
|
40.0%
8/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.6%
2/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
38.1%
8/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
37.5%
3/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
24.0%
6/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
29.6%
21/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
38.7%
29/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Flushing
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Haematoma
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
23.8%
5/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
18.3%
13/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.7%
11/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
1/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Hot flush
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
5/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
71.4%
5/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
42.9%
9/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
62.5%
5/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
40.0%
8/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.6%
6/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
4/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
23.8%
5/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
4/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
36.0%
9/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
4/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
20.0%
5/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.5%
6/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
9/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.0%
3/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
30.0%
6/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
4/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
32.0%
8/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.6%
4/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Influenza like illness
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.6%
6/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
37.5%
3/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
32.0%
8/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
22.5%
16/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.7%
11/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Infusion site extravasation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
International normalised ratio increased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
10/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
71.4%
5/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
71.4%
15/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
62.5%
5/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
3/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
48.0%
12/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
48.0%
12/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.4%
18/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
25/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
1/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Lymphocyte count decreased
|
45.0%
9/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
52.4%
11/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
75.0%
6/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Mucosal inflammation
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
10.7%
8/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
5/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.9%
7/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.6%
4/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
7/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
20.0%
5/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
15.5%
11/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
29.3%
22/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
6/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
4/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
71.4%
5/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
76.2%
16/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
62.5%
5/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
3/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
72.0%
18/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
60.0%
15/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
67.6%
48/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
73.3%
55/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
3/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
1/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Non-cardiac chest pain
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
3/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Pain
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
6.7%
5/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
25.0%
2/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.5%
6/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
17.3%
13/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.6%
4/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
28.0%
7/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
11.3%
8/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
21.3%
16/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
5.3%
4/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
6.7%
5/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Shock
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Sinusitis
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Skin candida
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.0%
1/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
19.0%
4/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.7%
2/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
80.0%
16/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
8/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
85.7%
6/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
76.2%
16/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
75.0%
6/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
3/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
76.0%
19/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
80.0%
20/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
73.2%
52/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
84.0%
63/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
66.7%
2/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
100.0%
2/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
1/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
20.0%
5/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.5%
6/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
12/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
50.0%
1/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
7.0%
5/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.3%
7/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
9.5%
2/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Eye disorders
Vision blurred
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
2/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.4%
1/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.5%
1/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
33.3%
1/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
12.0%
3/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
16.0%
4/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.2%
3/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Investigations
Weight decreased
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.8%
1/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
8.0%
6/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/20 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/7 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
14.3%
3/21 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/8 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
4.0%
1/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/25 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
2.8%
2/71 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
1.3%
1/75 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/3 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
0.00%
0/2 • Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".
|
Additional Information
Study Director
Teva Branded Pharmaceutical Products R&D LLC
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place