Trial Outcomes & Findings for A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults (NCT NCT06935266)
NCT ID: NCT06935266
Last Updated: 2026-08-17
Results Overview
A tolerable infusion was considered to have occurred if an infusion was completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any treatment-emergent adverse events (TEAEs) related to TAK-881. An infusion was considered to be tolerable if the participant had tolerated both the recombinant human hyaluronidase (rHuPH20) and immune globulin subcutaneous (IGSC) 20 percent (%) components of TAK-881. The number of participants who tolerated all initiated infusions by TAK-881 treatment were reported in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Up to Day 57
Results posted on
2026-08-17
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 22 April 2025 to 27 September 2025.
A total of 64 healthy adult participants were enrolled in the study. Cohort 1 (16 participants) evaluated a ramp-up dosing schedule (Schedule B) and no ramp-up dosing schedule (Schedule C). Cohort 2 and 3 (Each 24 participants) evaluated 2 ramp-up dosing schedules (Schedules A and B) and a no ramp-up dosing schedule (Schedule C).
Participant milestones
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
Participants received TAK-881 administered by subcutaneous (SC) infusion using a ramp-up dosing schedule of 0.15 grams per kilogram (g/kg) on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
6
|
8
|
8
|
7
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
0
|
0
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
Participants received TAK-881 administered by subcutaneous (SC) infusion using a ramp-up dosing schedule of 0.15 grams per kilogram (g/kg) on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Non-compliance
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
Baseline Characteristics
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
Total
n=64 Participants
Total of all reporting groups
|
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=24 Participants
|
8 Participants
n=23 Participants
|
8 Participants
n=28 Participants
|
60 Participants
n=26 Participants
|
7 Participants
n=51 Participants
|
7 Participants
n=51 Participants
|
8 Participants
n=102 Participants
|
8 Participants
n=18 Participants
|
7 Participants
n=74 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=24 Participants
|
8 Participants
n=23 Participants
|
8 Participants
n=28 Participants
|
64 Participants
n=26 Participants
|
8 Participants
n=51 Participants
|
8 Participants
n=51 Participants
|
8 Participants
n=102 Participants
|
8 Participants
n=18 Participants
|
8 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
2 Participants
n=28 Participants
|
37 Participants
n=26 Participants
|
4 Participants
n=51 Participants
|
8 Participants
n=51 Participants
|
7 Participants
n=102 Participants
|
4 Participants
n=18 Participants
|
5 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
6 Participants
n=28 Participants
|
27 Participants
n=26 Participants
|
4 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
4 Participants
n=18 Participants
|
3 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
4 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=28 Participants
|
9 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
6 Participants
n=28 Participants
|
54 Participants
n=26 Participants
|
7 Participants
n=51 Participants
|
6 Participants
n=51 Participants
|
7 Participants
n=102 Participants
|
8 Participants
n=18 Participants
|
6 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
PRIMARY outcome
Timeframe: Up to Day 57Population: The SAS included all participants who received any amount of TAK-881.
A tolerable infusion was considered to have occurred if an infusion was completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any treatment-emergent adverse events (TEAEs) related to TAK-881. An infusion was considered to be tolerable if the participant had tolerated both the recombinant human hyaluronidase (rHuPH20) and immune globulin subcutaneous (IGSC) 20 percent (%) components of TAK-881. The number of participants who tolerated all initiated infusions by TAK-881 treatment were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Tolerated All Initiated Infusions by TAK-881 Treatment
|
8 Participants
Interval 63.0 to 100.0
|
8 Participants
Interval 63.0 to 100.0
|
8 Participants
Interval 63.0 to 100.0
|
8 Participants
Interval 63.0 to 100.0
|
8 Participants
Interval 63.0 to 100.0
|
8 Participants
Interval 63.0 to 100.0
|
8 Participants
Interval 63.0 to 100.0
|
8 Participants
Interval 63.0 to 100.0
|
PRIMARY outcome
Timeframe: Up to Day 57Population: The SAS included all participants who received any amount of TAK-881. Here, 'overall number of units analyzed' refers to the total number of infusions administered for the TAK-881 treatment.
A tolerable infusion was considered to have occurred if an infusion was completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any TEAEs related to TAK-881. The number of tolerable infusions by TAK-881 treatment were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=31 total infusions
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=24 total infusions
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=35 total infusions
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=32 total infusions
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=24 total infusions
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=46 total infusions
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=42 total infusions
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=31 total infusions
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Tolerable Infusions by TAK-881 Treatment
|
31 number of infusions
Interval 89.0 to 100.0
|
24 number of infusions
Interval 86.0 to 100.0
|
35 number of infusions
Interval 90.0 to 100.0
|
32 number of infusions
Interval 89.0 to 100.0
|
24 number of infusions
Interval 86.0 to 100.0
|
46 number of infusions
Interval 92.0 to 100.0
|
42 number of infusions
Interval 92.0 to 100.0
|
31 number of infusions
Interval 89.0 to 100.0
|
SECONDARY outcome
Timeframe: From start of study drug administration up to end of trial (EOT) (up to Week 16)Population: The SAS included all participants who received any amount of TAK-881.
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the investigational product (IP), whether or not the occurrence was considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the IP. A TEAE was defined as any AE that was not present prior to the initiation of the treatments or any pre-existing AE that worsened in either intensity or frequency after receiving the first dose of trial intervention in this trial through 98 (±7) days after the last dose of trial intervention. Number of participants with TEAEs were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to EOT (up to Week 16)Population: The SAS included all participants who received any amount of TAK-881.
Clinical laboratory parameters included analysis of serum chemistry, hematology, coagulation and urinalysis. Clinical significance of laboratory values was determined at the investigator's discretion.
Outcome measures
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Serum Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Hematology
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Coagulation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Urinalysis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to EOT (up to Week 16)Population: The SAS included all participants who received any amount of TAK-881.
Vital signs parameters included measurement of pulse rate, blood pressure, body temperature and respiratory rate. Clinical significance of vital signs was determined at the investigator's discretion.
Outcome measures
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Pulse Rate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Blood Pressure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Body Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Respiratory Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: The SAS included all participants who received any amount of TAK-881.
The binding antibodies were considered as "positive" if corresponding titer was \>= 1:160. Number of participants with positive binding antibodies to rHuPH20 with titer \>=1:160 were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Binding Antibodies to rHuPH20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: The SAS included all participants who received any amount of TAK-881.
All participants were monitored for the formation of anti-rHuPH20 antibodies using validated anti-rHuPH20 antibody detection assay (also known as the screening and confirmatory binding assay). Post-dose samples with antibody titers \>=1 :160 were analyzed for the presence of neutralizing-ADA using a validated assay based on neutralization of rHuPH20 activity. Number of participants with neutralizing antibodies to anti-rHuPH20 were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 Participants
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 Participants
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Neutralizing Antibodies to Anti-rHuPH20
Participants with Positive Neutralizing Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Neutralizing Antibodies to Anti-rHuPH20
Participants with Negative Neutralizing Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: TAK-881 Ramp-up Schedule B
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 1: TAK-881 No Ramp-up Schedule C
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: TAK-881 Ramp-up Schedule A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: TAK-881 Ramp-up Schedule B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2: TAK-881 No Ramp-up Schedule C
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3: TAK-881 Ramp-up Schedule A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3: TAK-881 Ramp-up Schedule B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3: TAK-881 No Ramp-up Schedule C
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
Other adverse events
| Measure |
Cohort 1: TAK-881 Ramp-up Schedule B
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.15 g/kg on Day 1, 0.3 g/kg on Day 8, and 0.6 g/kg on Days 22 and 50.
|
Cohort 1: TAK-881 No Ramp-up Schedule C
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 0.6 g/kg on Days 1, 29, and 57.
|
Cohort 2: TAK-881 Ramp-up Schedule A
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50.
|
Cohort 2: TAK-881 Ramp-up Schedule B
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50.
|
Cohort 2: TAK-881 No Ramp-up Schedule C
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 1.0 g/kg on Days 1, 29, and 57.
|
Cohort 3: TAK-881 Ramp-up Schedule A
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50.
|
Cohort 3: TAK-881 Ramp-up Schedule B
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a ramp-up dosing schedule of 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50.
|
Cohort 3: TAK-881 No Ramp-up Schedule C
n=8 participants at risk
Participants received TAK-881 administered by SC infusion using a no ramp-up dosing schedule of 2.0 g/kg, on Days 1, 29, and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Fatigue
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Asthenia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Infections and infestations
Bacterial vaginosis
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Chills
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Feeling cold
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Feeling hot
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Reproductive system and breast disorders
Genital swelling
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
50.0%
4/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
62.5%
5/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
50.0%
4/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
62.5%
5/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
75.0%
6/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
87.5%
7/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Investigations
Heart rate increased
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site discharge
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site discolouration
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site discomfort
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site dysaesthesia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site erythema
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
87.5%
7/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site hypoaesthesia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site induration
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
87.5%
7/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site pain
|
62.5%
5/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
62.5%
5/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
50.0%
4/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
87.5%
7/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
75.0%
6/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
75.0%
6/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site paraesthesia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site pruritus
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
62.5%
5/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
87.5%
7/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
87.5%
7/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
62.5%
5/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site rash
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site reaction
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site scab
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site swelling
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
100.0%
8/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site ulcer
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Infusion site warmth
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
62.5%
5/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
75.0%
6/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Lip erythema
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Nodule
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Eye disorders
Photopsia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
25.0%
2/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Tenderness
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
12.5%
1/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
37.5%
3/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
0.00%
0/8 • From start of study drug administration up to EOT (up to Week 16)
The SAS included all participants who received any amount of TAK-881.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place