Trial Outcomes & Findings for First-in-Human Study of TAK-280 in Participants With Solid Tumors (NCT NCT05220098)
NCT ID: NCT05220098
Last Updated: 2026-07-07
Results Overview
DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Cycle 1 (Cycle length=28 days)
Results posted on
2026-07-07
Participant Flow
Participants took part in 20 investigative sites in the United States, Australia, Canada, and Spain from 21 April 2022 to 28 July 2025.
A total of 69 participants were enrolled and received study treatment in the dose-escalation phase. The study was terminated early by the sponsor due to the limited anti-cancer activity observed with TAK-280 during dose-escalation phase. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels A to J. The study ended early, so only dose-escalation phase was conducted.
Participant milestones
| Measure |
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: TAK-280 Dose Level A (Lowest)
STARTED
|
2
|
0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
|
Period 1: TAK-280 Dose Level A (Lowest)
COMPLETED
|
1
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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|
Period 1: TAK-280 Dose Level A (Lowest)
NOT COMPLETED
|
1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: TAK-280 Dose Level B
STARTED
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: TAK-280 Dose Level B
COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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|
Period 2: TAK-280 Dose Level B
NOT COMPLETED
|
0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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|
Period 3: TAK-280 Dose Level C
STARTED
|
0
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0
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3
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0
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0
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0
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0
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0
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0
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0
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|
Period 3: TAK-280 Dose Level C
COMPLETED
|
0
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0
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2
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0
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0
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0
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0
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0
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0
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0
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Period 3: TAK-280 Dose Level C
NOT COMPLETED
|
0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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|
Period 4: TAK-280 Dose Level D
STARTED
|
0
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0
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0
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5
|
0
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0
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0
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0
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0
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0
|
|
Period 4: TAK-280 Dose Level D
COMPLETED
|
0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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|
Period 4: TAK-280 Dose Level D
NOT COMPLETED
|
0
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0
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0
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4
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0
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0
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0
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0
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0
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0
|
|
Period 5: TAK-280 Dose Level E
STARTED
|
0
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0
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0
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0
|
5
|
0
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0
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0
|
0
|
0
|
|
Period 5: TAK-280 Dose Level E
COMPLETED
|
0
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0
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0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 5: TAK-280 Dose Level E
NOT COMPLETED
|
0
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0
|
0
|
0
|
4
|
0
|
0
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0
|
0
|
0
|
|
Period 6: TAK-280 Dose Level F
STARTED
|
0
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0
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0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Period 6: TAK-280 Dose Level F
COMPLETED
|
0
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0
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0
|
0
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0
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0
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0
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0
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0
|
0
|
|
Period 6: TAK-280 Dose Level F
NOT COMPLETED
|
0
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0
|
0
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0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Period 7: TAK-280 Dose Level G
STARTED
|
0
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0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
0
|
|
Period 7: TAK-280 Dose Level G
COMPLETED
|
0
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0
|
0
|
0
|
0
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0
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0
|
0
|
0
|
0
|
|
Period 7: TAK-280 Dose Level G
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
0
|
|
Period 8: TAK-280 Dose Level H
STARTED
|
0
|
0
|
0
|
0
|
0
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0
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0
|
12
|
0
|
0
|
|
Period 8: TAK-280 Dose Level H
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Period 8: TAK-280 Dose Level H
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
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0
|
9
|
0
|
0
|
|
Period 9: TAK-280 Dose Level I
STARTED
|
0
|
0
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0
|
0
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0
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0
|
0
|
0
|
26
|
0
|
|
Period 9: TAK-280 Dose Level I
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
|
Period 9: TAK-280 Dose Level I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
0
|
|
Period 10:TAK-280 Dose Level J (Highest)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Period 10:TAK-280 Dose Level J (Highest)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 10:TAK-280 Dose Level J (Highest)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: TAK-280 Dose Level A (Lowest)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: TAK-280 Dose Level B
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: TAK-280 Dose Level C
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4: TAK-280 Dose Level D
Death
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4: TAK-280 Dose Level D
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 5: TAK-280 Dose Level E
Death
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Period 5: TAK-280 Dose Level E
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 6: TAK-280 Dose Level F
Death
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Period 7: TAK-280 Dose Level G
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
|
Period 7: TAK-280 Dose Level G
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 8: TAK-280 Dose Level H
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Period 8: TAK-280 Dose Level H
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 8: TAK-280 Dose Level H
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Period 9: TAK-280 Dose Level I
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Period 9: TAK-280 Dose Level I
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
0
|
|
Period 9: TAK-280 Dose Level I
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Period 10:TAK-280 Dose Level J (Highest)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 10:TAK-280 Dose Level J (Highest)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
First-in-Human Study of TAK-280 in Participants With Solid Tumors
Baseline characteristics by cohort
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=5 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=8 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=12 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=26 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 7.07 • n=20 Participants
|
61.0 years
STANDARD_DEVIATION NA • n=20 Participants
|
68.0 years
STANDARD_DEVIATION 10.54 • n=40 Participants
|
57.0 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 12.85 • n=9 Participants
|
65.8 years
STANDARD_DEVIATION 1.92 • n=6 Participants
|
64.0 years
STANDARD_DEVIATION 8.49 • n=6 Participants
|
60.3 years
STANDARD_DEVIATION 13.14 • n=6 Participants
|
60.0 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 2.83 • n=6 Participants
|
61.3 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
15 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
24 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
24 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Cycle length=28 days)Population: The DLT-evaluable analysis set included all participants in the dose-escalation phase who had received at least 3 doses of TAK-280 or had a DLT within the DLT-evaluation period. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.
Outcome measures
| Measure |
TAK-280, Dose A
n=1 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=4 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=4 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=9 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=7 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to follow-up (up to 37 weeks)Population: The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE was defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of new anticancer therapy. AEs were evaluated according to NCI CTCAE, Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=5 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=8 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=12 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=26 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
12 Participants
|
26 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)Population: The pharmacokinetics (PK) analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Cmax for TAK-280 was reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=4 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=2 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=11 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=18 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of TAK-280
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was below limit of quantification (BLQ).
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
3.74 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27.0
|
16.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.4
|
8.91 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 13.7
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
12.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.8
|
18.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 107.0
|
21.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 95.3
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
SECONDARY outcome
Timeframe: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)Population: The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
AUC0-last for TAK-280 was reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=3 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=2 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=11 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=18 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) of TAK- 280
|
NA hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
26.4 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 96.1
|
270 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 39.8
|
106 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 46.7
|
NA hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
166 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 45.9
|
235 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 61.1
|
318 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 40.5
|
NA hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
SECONDARY outcome
Timeframe: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)Population: The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
AUC0-inf for TAK-280 was reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=2 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=1 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=2 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=5 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=8 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=1 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of TAK-280
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means there were not enough samples collected in the elimination phase to estimate the PK parameter
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means there were not enough samples collected in the elimination phase to estimate the PK parameter
|
268 h*ng/mL
Geometric Coefficient of Variation 65.0
|
420 h*ng/mL
Geometric Coefficient of Variation 58.7
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ
|
SECONDARY outcome
Timeframe: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)Population: The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Tmax for TAK-280 was reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=4 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=2 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=11 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=18 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of TAK-280
|
NA hours
NA means data could not be calculated because concentration was BLQ.
|
NA hours
NA means data could not be calculated because concentration was BLQ.
|
1.02 hours
Interval 1.02 to 1.12
|
1.10 hours
Interval 1.07 to 1.17
|
1.01 hours
Interval 1.0 to 1.73
|
1.15 hours
Interval 1.12 to 1.17
|
1.09 hours
Interval 1.02 to 1.15
|
1.10 hours
Interval 1.03 to 1.2
|
1.22 hours
Interval 1.0 to 6.17
|
1.08 hours
Interval 1.07 to 1.08
|
SECONDARY outcome
Timeframe: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)Population: The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
T1/2 was reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=3 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=2 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=11 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=17 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Disposition Phase Half-Life (t1/2) of TAK-280
|
NA hours
NA means data could not be calculated because concentration was BLQ.
|
NA hours
NA means data could not be calculated because concentration was BLQ.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
NA hours
Median and full range was not calculable due to insufficient number of valid PK sampling.
|
SECONDARY outcome
Timeframe: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)Population: The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
CL of TAK-280 was reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=2 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=1 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=2 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=5 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=8 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=1 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) of TAK-280
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
|
0.0168 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 65.0
|
0.0143 liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 58.7
|
NA liters per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
SECONDARY outcome
Timeframe: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)Population: The PK analysis set included all participants who received at least one dose of TAK-280 and had sufficient PK data to reliably estimate one or more PK parameters. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Vss of TAK-280 was reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=2 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=1 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=2 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=5 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=8 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=1 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means there were not enough samples collected in the elimination phase to estimate the PK parameter.
|
0.344 liters per kilogram (L/kg)
Geometric Coefficient of Variation 52.2
|
0.273 liters per kilogram (L/kg)
Geometric Coefficient of Variation 45.3
|
NA liters per kilogram (L/kg)
Geometric Coefficient of Variation NA
NA means data could not be calculated because concentration was BLQ.
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
ORR was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) as defined by the Investigator based on radiologic criteria. ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: At least a 30 percentage (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=5 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=8 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=12 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=26 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 52.2
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 36.9
|
0 percentage of participants
Interval 0.0 to 26.5
|
0 percentage of participants
Interval 0.0 to 13.2
|
0 percentage of participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: The safety analysis set consisted of all participants who received at least 1 dose of TAK-280. Here, "Overall number of participants analyzed" signifies participants who had a OR.
The DOR was assessed according to RECIST version 1.1. and defined as time from the date of first documentation of a PR or better to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurred first, for participants with a confirmed response (PR or better). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
PFS was assessed according to RECIST version 1.1 and was defined as the time from the date of first dose of TAK-280 to the date of first documentation of PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=5 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=8 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=12 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=26 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
13.7 weeks
Interval 4.0 to 23.4
|
6.3 weeks
Interval 6.3 to 6.3
|
8.4 weeks
Interval 6.4 to 23.3
|
9.6 weeks
Interval 4.1 to 20.0
|
5.4 weeks
Interval 4.3 to 57.0
|
7.0 weeks
Interval 0.1 to 15.6
|
8.1 weeks
Interval 0.1 to 15.9
|
7.4 weeks
Interval 0.1 to 19.0
|
9.0 weeks
Interval 0.1 to 32.1
|
7.7 weeks
Interval 4.3 to 7.7
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
OS was defined as the time from the date of first dose TAK-280 until death due to any cause.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=5 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=8 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=12 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=26 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA weeks
Interval 9.7 to
Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
21.9 weeks
Lower and upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
NA weeks
Interval 7.0 to
Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
11.9 weeks
Interval 9.6 to
Upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
38.7 weeks
Interval 5.4 to
Upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
24.3 weeks
Interval 6.6 to
Upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
36.7 weeks
Interval 10.3 to 39.7
|
32.3 weeks
Interval 6.0 to
Upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
NA weeks
Interval 25.1 to
Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
NA weeks
Interval 11.4 to
Median and upper 95% CI value could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: The safety analysis set consisted of all participants who received at least 1 dose of TAK-280.
DCR was defined as the percentage of participants who achieved PR, CR, or stable disease (SD) with a duration of \>=2 consecutive scans determined by the investigator as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=5 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=8 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=12 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=26 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
0 percentage of participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: PSA response analysis set included all participants with mCRPC who received at least 1 dose of TAK-280 Dose A to Dose J in dose escalation part and with a baseline elevation of PSA, who had at least 1 post infusion PSA value, or treatment discontinuation due to AE, clinical progression or death before post infusion PSA sample was collected. The analysis was done for a subset of participants with mCRPC and no per arm data was collected as pre-specified in the analysis plan.
PSA response was defined as a reduction in baseline PSA level of greater than or equal to (\>=) 50% maintained for at least 3 weeks in participants with mCRPC.
Outcome measures
| Measure |
TAK-280, Dose A
n=8 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: PSA response analysis set included all participants with mCRPC who received at least 1 dose of TAK-280 Dose A to Dose J in dose escalation part and with a baseline elevation of PSA, who had at least 1 post infusion PSA value, or treatment discontinuation due to AE, clinical progression or death before post infusion PSA sample was collected.
Duration of PSA response was the time from the date of the first PSA response to the date of the first documented PSA progression in participants with mCRPC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: PSA response analysis set was used. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. The analysis was done for a subset of participants with mCRPC and no per arm data was collected as pre-specified in the analysis plan.
Time to PSA progression was the time from the date of the first dose of TAK-280 to the date that an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir in participants with mCRPC.
Outcome measures
| Measure |
TAK-280, Dose A
n=6 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to PSA Progression in Participants With mCRPC
|
8.1 weeks
Interval 3.1 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: PSA response analysis set included all participants with mCRPC who received at least 1 dose of TAK-280 Dose A to Dose J in dose escalation part and with a baseline elevation of PSA, who had at least 1 post infusion PSA value, or treatment discontinuation due to AE, clinical progression or death before post infusion PSA sample was collected. The analysis was done for a subset of participants with mCRPC and no per arm data was collected as pre-specified in the analysis plan.
PSA response was defined as a reduction in baseline PSA level of \>=50% maintained for at 6 months in participants with mCRPC.
Outcome measures
| Measure |
TAK-280, Dose A
n=8 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With PSA Reductions of >=50% at 6 Months
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: Immunogenicity analysis set included all participants who received at least 1 dose of TAK-280 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Number of participants who were negative for TAK-280 at baseline and became positive were reported.
Outcome measures
| Measure |
TAK-280, Dose A
n=2 Participants
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
n=1 Participants
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=3 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=5 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=5 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=5 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=7 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=12 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=26 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
22 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: Immunogenicity analysis set included all participants who received at least 1 dose of TAK-280 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment. Here "overall number of participants analyzed" signifies participants who developed positive induced ADA to TAK-280 and gave consent to participate in the assessment for this outcome.
Number of participants who developed B7-H3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.
Outcome measures
| Measure |
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=2 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=2 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=4 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=4 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=9 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=19 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed B7-H3 Targeted Neutralizing Antibodies (NAb) to TAK 280
Participants positive for B7-H3 NAb
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
2 Participants
|
|
Number of Participants Who Developed B7-H3 Targeted Neutralizing Antibodies (NAb) to TAK 280
Participants negative for B7 -H3 NAb
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Who Developed B7-H3 Targeted Neutralizing Antibodies (NAb) to TAK 280
Unknown participants for B7-H3 Nab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: Immunogenicity analysis set included all participants who received at least 1 dose of TAK-280 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment. Here "overall number of participants analyzed" signifies participants who developed positive induced ADA to TAK-280 and gave consent to participate in the assessment for this outcome.
Number of participants who developed CD3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.
Outcome measures
| Measure |
TAK-280, Dose A
Participants received TAK-280, Dose A intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level A is the lowest dose level.
|
TAK-280, Dose B
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level B is greater than dose level A.
|
TAK-280, Dose C
n=2 Participants
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level C is greater than dose level B.
|
TAK-280, Dose D
n=2 Participants
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level D is greater than dose level C.
|
TAK-280, Dose E
n=4 Participants
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level E is greater than dose level D.
|
TAK-280, Dose F
n=4 Participants
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level F is greater than dose level E.
|
TAK-280, Dose G
n=6 Participants
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level G is greater than dose level F.
|
TAK-280, Dose H
n=9 Participants
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level H is greater than dose level G.
|
TAK-280, Dose I
n=19 Participants
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level I is greater than dose level H.
|
TAK-280, Dose J
n=2 Participants
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs. Dose level J is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed CD3 Targeted Neutralizing Antibodies to TAK 280
Unknown participants for CD3 Nab
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Who Developed CD3 Targeted Neutralizing Antibodies to TAK 280
Participants positive for CD3 NAb
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Who Developed CD3 Targeted Neutralizing Antibodies to TAK 280
Participants negative for CD3 NAb
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
TAK-280 Dose H
Serious events: 8 serious events
Other events: 12 other events
Deaths: 6 deaths
TAK-280 Dose A
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
TAK-280 Dose B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
TAK-280 Dose C
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
TAK-280 Dose D
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
TAK-280 Dose E
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
TAK-280 Dose F
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
TAK-280 Dose G
Serious events: 6 serious events
Other events: 8 other events
Deaths: 7 deaths
TAK-280 Dose I
Serious events: 14 serious events
Other events: 26 other events
Deaths: 5 deaths
TAK-280 Dose J
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TAK-280 Dose H
n=12 participants at risk
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose A
n=2 participants at risk
Participants received TAK-280, Dose A IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose B
n=1 participants at risk
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose C
n=3 participants at risk
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose D
n=5 participants at risk
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose E
n=5 participants at risk
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose F
n=5 participants at risk
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose G
n=8 participants at risk
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose I
n=26 participants at risk
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose J
n=2 participants at risk
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Asthenia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
37.5%
3/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
26.9%
7/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Fatigue
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
General physical health deterioration
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Infusion site thrombosis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Renal and urinary disorders
Nephropathy toxic
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Thoracic radiculopathy
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
Other adverse events
| Measure |
TAK-280 Dose H
n=12 participants at risk
Participants received TAK-280, Dose H IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose A
n=2 participants at risk
Participants received TAK-280, Dose A IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose B
n=1 participants at risk
Participants received TAK-280, Dose B IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose C
n=3 participants at risk
Participants received TAK-280, Dose C IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose D
n=5 participants at risk
Participants received TAK-280, Dose D IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose E
n=5 participants at risk
Participants received TAK-280, Dose E IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose F
n=5 participants at risk
Participants received TAK-280, Dose F IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose G
n=8 participants at risk
Participants received TAK-280, Dose G IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose I
n=26 participants at risk
Participants received TAK-280, Dose I IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
TAK-280 Dose J
n=2 participants at risk
Participants received TAK-280, Dose J IV infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
37.5%
3/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Pallor
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Malaise
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to vagina
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Motor dysfunction
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Mucosal inflammation
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
15.4%
4/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Oesophageal compression
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Phlebitis
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Platelet count decreased
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Protein total decreased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Pyrexia
|
25.0%
3/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Rash pustular
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Sciatica
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Specific gravity urine increased
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Transaminases increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Urine output increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
19.2%
5/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Weight decreased
|
25.0%
3/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
37.5%
3/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Activated partial thromboplastin time shortened
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Endocrine disorders
Adrenal insufficiency
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
6/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
65.4%
17/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
2/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Amylase increased
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Blood and lymphatic system disorders
Anaemia
|
41.7%
5/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
4/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
19.2%
5/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Ascites
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Aspartate aminotransferase increased
|
41.7%
5/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
37.5%
3/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
61.5%
16/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Asthenia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
4/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Blood iron decreased
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Blood urea increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Body temperature increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
COVID-19
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Catheter site erythema
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Chills
|
33.3%
4/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
15.4%
4/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Cognitive disorder
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
19.2%
5/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Immune system disorders
Cytokine release syndrome
|
25.0%
3/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
80.0%
4/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
4/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
65.4%
17/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
2/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
37.5%
3/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Embolism
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Fatigue
|
33.3%
4/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
80.0%
4/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
4/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
19.2%
5/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Feeling hot
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Flushing
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Gait disturbance
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
60.0%
3/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Hot flush
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
4/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
33.3%
1/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
7.7%
2/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Vascular disorders
Hypotension
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
100.0%
1/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Immature granulocyte count increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Infusion site rash
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
General disorders
Injection site reaction
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
40.0%
2/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Infections and infestations
Lip infection
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
12.5%
1/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Lipase increased
|
16.7%
2/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
50.0%
1/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Liver function test increased
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
3/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
20.0%
1/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
25.0%
2/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
11.5%
3/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
1/12 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/1 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/3 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/5 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/8 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
3.8%
1/26 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
0.00%
0/2 • From start of study drug administration up to follow-up (up to 37 weeks)
Safety analysis set was the group of participants who received at least 1 dose of TAK-280.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place