Trial Outcomes & Findings for A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia (NCT NCT04278924)

Last Updated: 2025-06-15

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with the treatment. SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening; c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. TEAEs were defined as an AE having a start date and time equal to or later than the start date and time of the first dose of investigational medicinal product (IMP). Percentages were rounded off to the nearest single decimal place.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Up to Week 32 in each Period of the study

Results posted on

2025-06-15

Participant Flow

Participants took part in the study at 24 investigative sites globally from 09 November 2020 to 29 April 2024.

Participants who had persistent/chronic primary immune thrombocytopenia (ITP) were randomized to receive either mezagitamab (TAK-079) or matching placebo in Part A or Part B of this study.

Participant milestones

Participant milestones
Measure	Part A & B: Double Blind Period: Placebo Participants received TAK-079 placebo-matching injection subcutaneously (SC), once weekly (QW) for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded short follow-up period (SFP) up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded long follow-up period (LFP) up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Double Blind Period (Main Study) STARTED	13	9	8	11	0	0	0
Double Blind Period (Main Study) COMPLETED	12	7	8	9	0	0	0
Double Blind Period (Main Study) NOT COMPLETED	1	2	0	2	0	0	0
Open-label Extension Period STARTED	0	0	0	0	4	4	4
Open-label Extension Period COMPLETED	0	0	0	0	4	4	4
Open-label Extension Period NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A & B: Double Blind Period: Placebo Participants received TAK-079 placebo-matching injection subcutaneously (SC), once weekly (QW) for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded short follow-up period (SFP) up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded long follow-up period (LFP) up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Double Blind Period (Main Study) Withdrawal by Subject	1	1	0	2	0	0	0
Double Blind Period (Main Study) Reason Not Specified	0	1	0	0	0	0	0

Baseline Characteristics

A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A & B: Double Blind Period: Placebo n=13 Participants Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=9 Participants Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=8 Participants Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=11 Participants Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Total n=41 Participants Total of all reporting groups
Age, Continuous	38.8 years STANDARD_DEVIATION 15.86 • n=5 Participants	49.0 years STANDARD_DEVIATION 14.45 • n=7 Participants	52.3 years STANDARD_DEVIATION 16.59 • n=5 Participants	48.4 years STANDARD_DEVIATION 19.68 • n=4 Participants	46.2 years STANDARD_DEVIATION 17.03 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants	28 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	38 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	37 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Week 32 in each Period of the study

Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Part A & B: Double Blind Period: Placebo n=13 Participants Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=9 Participants Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=8 Participants Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=11 Participants Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg n=4 Participants Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Percentage of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (SAE), and TEAEs Leading to TAK-079 Discontinuation Grade 3 or Higher TEAE	23.1 percentage of participants	22.2 percentage of participants	0 percentage of participants	27.3 percentage of participants	0 percentage of participants	0 percentage of participants	25.0 percentage of participants
Percentage of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (SAE), and TEAEs Leading to TAK-079 Discontinuation Treatment Emergent SAE	7.7 percentage of participants	22.2 percentage of participants	0 percentage of participants	18.2 percentage of participants	25.0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (SAE), and TEAEs Leading to TAK-079 Discontinuation TEAEs Leading to TAK-079 Discontinuation	0 percentage of participants	22.2 percentage of participants	0 percentage of participants	18.2 percentage of participants	25.0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 16 and 32

Population: The Full Analysis Set included all randomized participants who had received at least 1 dose of study drug. Number analyzed indicates the number of participants with data available for analyses at the specified time point. All participants in the 'Part A \& B: Double Blind Period: Placebo' arm either transitioned to OLE Period or discontinued from the study prior to Week 32.

Platelet response is defined as a platelet count ≥50,000/microliter (μL) and ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure	Part A & B: Double Blind Period: Placebo n=13 Participants Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=9 Participants Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=8 Participants Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=11 Participants Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg n=4 Participants Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Percentage of Participants With Platelet Response at Weeks 16 and 32 Week 16	23.08 percentage of participants Interval 5.04 to 53.81	66.67 percentage of participants Interval 29.93 to 92.51	62.50 percentage of participants Interval 24.49 to 91.48	90.91 percentage of participants Interval 58.72 to 99.77	50.00 percentage of participants Interval 6.76 to 93.24	50.00 percentage of participants Interval 6.76 to 93.24	25.00 percentage of participants Interval 0.63 to 80.59
Percentage of Participants With Platelet Response at Weeks 16 and 32 Week 32	—	66.67 percentage of participants Interval 29.93 to 92.51	62.50 percentage of participants Interval 24.49 to 91.48	90.91 percentage of participants Interval 58.72 to 99.77	50.00 percentage of participants Interval 6.76 to 93.24	50.00 percentage of participants Interval 6.76 to 93.24	25.00 percentage of participants Interval 0.63 to 80.59

SECONDARY outcome

Timeframe: At Weeks 16 and 32

Population: The Full Analysis Set consisted of all randomized participants who had received at least 1 dose of study drug. Number analyzed indicates the number of participants with data available for analyses at the specified time point. All participants in the 'Part A \& B: Double Blind Period: Placebo' arm either transitioned to OLE Period or discontinued from the study prior to Week 32.

Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure	Part A & B: Double Blind Period: Placebo n=13 Participants Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=9 Participants Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=8 Participants Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=11 Participants Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg n=4 Participants Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Percentage of Participants With Complete Platelet Response at Weeks 16 and 32 Week 16	0 percentage of participants Interval 0.0 to 24.71	55.56 percentage of participants Interval 21.2 to 86.3	50.00 percentage of participants Interval 15.7 to 84.3	81.82 percentage of participants Interval 48.22 to 97.72	0 percentage of participants Interval 0.0 to 60.24	25.00 percentage of participants Interval 0.63 to 80.59	25.00 percentage of participants Interval 0.63 to 80.59
Percentage of Participants With Complete Platelet Response at Weeks 16 and 32 Week 32	—	55.56 percentage of participants Interval 21.2 to 86.3	50.00 percentage of participants Interval 15.7 to 84.3	81.82 percentage of participants Interval 48.22 to 97.72	25.00 percentage of participants Interval 0.63 to 80.59	25.00 percentage of participants Interval 0.63 to 80.59	25.00 percentage of participants Interval 0.63 to 80.59

SECONDARY outcome

Timeframe: At Weeks 16 and 32

A clinically meaningful platelet response is defined as a platelet count ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure	Part A & B: Double Blind Period: Placebo n=13 Participants Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=9 Participants Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=8 Participants Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=11 Participants Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg n=4 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg n=4 Participants Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Percentage of Participants With Clinically Meaningful Platelet Response at Weeks 16 and 32 Week 16	30.77 percentage of participants Interval 9.09 to 61.43	66.67 percentage of participants Interval 29.93 to 92.51	75.00 percentage of participants Interval 34.91 to 96.81	90.91 percentage of participants Interval 58.72 to 99.77	75.00 percentage of participants Interval 19.41 to 99.37	50.00 percentage of participants Interval 6.76 to 93.24	25.00 percentage of participants Interval 0.63 to 80.59
Percentage of Participants With Clinically Meaningful Platelet Response at Weeks 16 and 32 Week 32	—	66.67 percentage of participants Interval 29.93 to 92.51	75.00 percentage of participants Interval 34.91 to 96.81	90.91 percentage of participants Interval 58.72 to 99.77	75.00 percentage of participants Interval 19.41 to 99.37	50.00 percentage of participants Interval 6.76 to 93.24	25.00 percentage of participants Interval 0.63 to 80.59

SECONDARY outcome

Timeframe: At Weeks 16 and 32

Population: The Full Analysis Set included all randomized participants who had received at least 1 dose of study drug. Overall number of participants indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at the specified time point. All participants in the 'Part A \& B: Double Blind Period: Placebo' arm either transitioned to OLE Period or discontinued from the study prior to Week 32.

A hemostatic platelet response is defined for participants with a baseline platelet count of \<15,000/μL who achieved a platelet count of ≥30,000/μL and ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure	Part A & B: Double Blind Period: Placebo n=5 Participants Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=5 Participants Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=4 Participants Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=4 Participants Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg n=2 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg n=1 Participants Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg n=3 Participants Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Percentage of Participants With Hemostatic Platelet Response at Weeks 16 and 32 Week 16	0 percentage of participants Interval 0.0 to 52.18	40.00 percentage of participants Interval 5.27 to 85.34	25.00 percentage of participants Interval 0.63 to 80.59	100.00 percentage of participants Interval 39.76 to 100.0	100.00 percentage of participants Interval 15.81 to 100.0	100.00 percentage of participants Interval 2.5 to 100.0	0 percentage of participants Interval 0.0 to 70.76
Percentage of Participants With Hemostatic Platelet Response at Weeks 16 and 32 Week 32	—	40.00 percentage of participants Interval 5.27 to 85.34	25.00 percentage of participants Interval 0.63 to 80.59	100.00 percentage of participants Interval 39.76 to 100.0	100.00 percentage of participants Interval 15.81 to 100.0	100.00 percentage of participants Interval 2.5 to 100.0	0 percentage of participants Interval 0.0 to 70.76

Adverse Events

Part A & B: Double Blind Period: Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Part A: Double Blind Period: TAK-079 100 mg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Part A: Double Blind Period: TAK-079 300 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B: Double Blind Period: TAK-079 600 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: Open-label Extension (OLE) Period: TAK-079 100 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: OLE Period: TAK-079 300 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B: OLE Period: TAK-079 600 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A & B: Double Blind Period: Placebo n=13 participants at risk Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=9 participants at risk Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=8 participants at risk Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=11 participants at risk Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg n=4 participants at risk Participants who received placebo in double-blind Part A and SFP and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg n=4 participants at risk Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg n=4 participants at risk Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Renal and urinary disorders Acute kidney injury	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Conjunctivitis allergic	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pyelonephritis chronic	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Part A & B: Double Blind Period: Placebo n=13 participants at risk Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 100 mg n=9 participants at risk Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Double Blind Period: TAK-079 300 mg n=8 participants at risk Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part B: Double Blind Period: TAK-079 600 mg n=11 participants at risk Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.	Part A: Open-label Extension (OLE) Period: TAK-079 100 mg n=4 participants at risk Participants who received placebo in double-blind Part A and SFP and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part A: OLE Period: TAK-079 300 mg n=4 participants at risk Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.	Part B: OLE Period: TAK-079 600 mg n=4 participants at risk Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 2/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Administration site haematoma	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 2/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Anal fissure	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Aortic aneurysm	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Asthenia	15.4% 2/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Bacteriuria	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Blood urine present	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	22.2% 2/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Conjunctival haemorrhage	15.4% 2/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	15.4% 2/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Electrocardiogram abnormal	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Essential hypertension	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Feeling cold	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival bleeding	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Glossitis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haematochezia	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Haematoma	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Heavy menstrual bleeding	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Influenza like illness	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Injection related reaction	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Injection site bruising	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Injection site cellulitis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Injection site haematoma	23.1% 3/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 2/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Injection site reaction	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Iron deficiency	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Joint injury	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Myopia	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Nystagmus	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Optic neuropathy	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	15.4% 2/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Post-traumatic headache	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	18.2% 2/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Thrombophlebitis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary retention	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	7.7% 1/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Vocal cord paralysis	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 1/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/13 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/9 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Up to Week 32 in each Period of the study The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place