Trial Outcomes & Findings for A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations (NCT NCT02962960)

NCT ID: NCT02962960

Last Updated: 2023-01-12

Results Overview

Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: Week 0
• Results posted on: 2023-01-12

Participant Flow

Participants type I Interferon (IFN) test-high Systemic Lupus Erythematosus (SLE) subjects with active skin manifestations while receiving Standard of Care (SOC) treatment were eligible for the study.

36 patients were randomized, and all received at least one dose of study treatment.

Participant milestones

Measure	Anifrolumab - Lower Dose 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
Overall Study STARTED	14	13	9
Overall Study COMPLETED	11	11	9
Overall Study NOT COMPLETED	3	2	0

Reasons for withdrawal

Measure	Anifrolumab - Lower Dose 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
Overall Study Withdrawal by Subject	1	1	0
Overall Study Adverse Event	1	1	0
Overall Study Protocol Violation	1	0	0

Baseline Characteristics

A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

Baseline characteristics by cohort

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Total n=36 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 9.1 • n=5 Participants	41.5 years STANDARD_DEVIATION 9.2 • n=7 Participants	47.8 years STANDARD_DEVIATION 14.2 • n=5 Participants	44.9 years STANDARD_DEVIATION 10.6 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 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
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
Race (NIH/OMB) White	8 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0

Population: All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.

Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.

Outcome measures

Measure	Anifrolumab - Lower Dose n=13 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Maximum Concentration of Anifrolumab in Serum After First Dose	14.058 mcg/mL Geometric Coefficient of Variation 49.8151	28.115 mcg/mL Geometric Coefficient of Variation 74.4916	—	—

PRIMARY outcome

Timeframe: Week 12

Population: All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.

Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).

Outcome measures

Measure	Anifrolumab - Lower Dose n=11 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=11 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab	15.618 mcg/mL Geometric Coefficient of Variation 81.3595	16.926 mcg/mL Geometric Coefficient of Variation 9205.6677	—	—

PRIMARY outcome

Timeframe: Week 12

Population: All participants who are 21-gene IFN test high at baseline.

21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.

Outcome measures

Measure	Anifrolumab - Lower Dose n=11 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=11 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
21-gene Type 1 IFN Signature Score (Fold-change)	3.2 fold change Standard Deviation 3.69	3.5 fold change Standard Deviation 5.73	14.3 fold change Standard Deviation 6.68	—

PRIMARY outcome

Timeframe: Week 12

Population: All participants who are 21-gene IFN test high at baseline.

21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)*100) for the 21 genes. At a population level, the results are presented as mean the above.

Outcome measures

Measure	Anifrolumab - Lower Dose n=11 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=11 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change)	77.5 percentage neutralization Standard Deviation 24.16	80.5 percentage neutralization Standard Deviation 36.65	15.1 percentage neutralization Standard Deviation 49.63	—

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Number of Participants With Antidrug Antibody (ADA)	1 Participants	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Incidence of detectable nAb in post-baseline ADA positive participants.

Outcome measures

Measure	Anifrolumab - Lower Dose n=1 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=1 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Number of Participants With Neutralizing Antibodies (nAb)	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) Any adverse event	12 Participants	11 Participants	7 Participants	—
Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) Any serious adverse event	4 Participants	2 Participants	0 Participants	—
Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) Any adverse event of special interest	5 Participants	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline for vital signs.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Change From Baseline for Vital Signs Systolic Blood Pressure (mmHg) - Week 12	-4.1 mmHg Standard Deviation 12.08	3 mmHg Standard Deviation 6.63	-5.8 mmHg Standard Deviation 13.99	7.3 mmHg Standard Deviation 8.96
Change From Baseline for Vital Signs Systolic Blood Pressure (mmHg) - Week 52	2.1 mmHg Standard Deviation 10.96	-1.7 mmHg Standard Deviation 12.96	3.4 mmHg Standard Deviation 8.53	12.5 mmHg Standard Deviation 19.36
Change From Baseline for Vital Signs Systolic Blood Pressure (mmHg) - Week 60	4.1 mmHg Standard Deviation 19.70	-2.8 mmHg Standard Deviation 14.91	12.2 mmHg Standard Deviation 8.61	4.5 mmHg Standard Deviation 7.14
Change From Baseline for Vital Signs Diastolic Blood Pressure (mmHg) - Week 12	-2.0 mmHg Standard Deviation 10.02	2.4 mmHg Standard Deviation 6.71	-3.8 mmHg Standard Deviation 6.50	4.3 mmHg Standard Deviation 4.35
Change From Baseline for Vital Signs Diastolic Blood Pressure (mmHg) - Week 52	0.1 mmHg Standard Deviation 6.87	2.9 mmHg Standard Deviation 7.54	-0.4 mmHg Standard Deviation 7.13	6.8 mmHg Standard Deviation 5.38
Change From Baseline for Vital Signs Diastolic Blood Pressure (mmHg) - Week 60	3.6 mmHg Standard Deviation 12.23	-0.8 mmHg Standard Deviation 6.86	-1.0 mmHg Standard Deviation 8.22	8.8 mmHg Standard Deviation 6.29

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Physical examination is reported as change from baseline in body weight.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Change From Baseline for Physical Examination Week 12	-1.81 kilograms Standard Deviation 2.674	1.37 kilograms Standard Deviation 3.113	0.7 kilograms Standard Deviation 1.889	0.98 kilograms Standard Deviation 2.904
Change From Baseline for Physical Examination Week 52	-2.83 kilograms Standard Deviation 4.683	2.52 kilograms Standard Deviation 6.495	0.30 kilograms Standard Deviation 3.338	3.90 kilograms Standard Deviation 5.608
Change From Baseline for Physical Examination Week 60	-1.81 kilograms Standard Deviation 3.858	2.93 kilograms Standard Deviation 6.463	1.06 kilograms Standard Deviation 4.020	3.60 kilograms Standard Deviation 5.300

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant [NCS]), abnormal (clinically significant [CS]), or not done.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Change From Baseline for 12-lead ECG Normal baseline - Normal Week 52	7 Participants	10 Participants	5 Participants	3 Participants
Change From Baseline for 12-lead ECG Normal baseline - Abnormal (NCS) Week 52	1 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Normal baseline - not done Week 52	1 Participants	2 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Abnormal (NCS) baseline - Normal Week 52	2 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline for 12-lead ECG Abnormal (NCS) baseline - Abnormal (NCS) Week 52	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Abnormal (NCS) baseline - not done Week 52	2 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Not done baseline - Normal Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Not done baseline - Abnormal (NCS) Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Not done baseline - Not done Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Normal baseline - Abnormal (CS) Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Abnormal (NCS) baseline - Abnormal (CS) Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Not done baseline - Abnormal (CS) Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Abnormal (CS) baseline - Normal Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Abnormal (CS) baseline - Abnormal (CS) Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Abnormal (CS) baseline - Not done Week 52	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline for 12-lead ECG Abnormal (CS) baseline - Abnormal (NCS) Week 52	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline in haemoglobin blood tests are reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Haemoglobin Blood Test to Detect Change From Baseline Haemoglobin - Week 12	-0.2 g/L Standard Deviation 9.07	0.7 g/L Standard Deviation 7.4	-0.5 g/L Standard Deviation 7.14	4.8 g/L Standard Deviation 5.91
Value of Haemoglobin Blood Test to Detect Change From Baseline Haemoglobin - Week 52	-1.1 g/L Standard Deviation 13.92	0.1 g/L Standard Deviation 11.65	-4.8 g/L Standard Deviation 3.83	7 g/L Standard Deviation 5.94
Value of Haemoglobin Blood Test to Detect Change From Baseline Haemoglobin - Week 60	0.8 g/L Standard Deviation 12.97	0 g/L Standard Deviation 10.43	-5.4 g/L Standard Deviation 5.68	5.8 g/L Standard Deviation 6.85

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline in haematology blood tests (leucocytes [particle concentration], platelets [particle concentration]) are reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Haematology Blood Tests to Detect Change From Baseline Leucocytes - Week 12	0.491 10^9/L Standard Deviation 1.5806	3.165 10^9/L Standard Deviation 2.2706	0.867 10^9/L Standard Deviation 1.0999	1.96 10^9/L Standard Deviation 1.9487
Value of Haematology Blood Tests to Detect Change From Baseline Leucocytes - Week 52	1.041 10^9/L Standard Deviation 1.5794	2.457 10^9/L Standard Deviation 2.3891	0.236 10^9/L Standard Deviation 1.0107	0.080 10^9/L Standard Deviation 1.4798
Value of Haematology Blood Tests to Detect Change From Baseline Leucocytes - Week 60	-0.012 10^9/L Standard Deviation 1.5489	1.474 10^9/L Standard Deviation 1.6490	0.776 10^9/L Standard Deviation 2.1779	1.23 10^9/L Standard Deviation 1.6687
Value of Haematology Blood Tests to Detect Change From Baseline Platelets - Week 12	7.8 10^9/L Standard Deviation 65.28	45.2 10^9/L Standard Deviation 67.41	10.3 10^9/L Standard Deviation 24.54	17.0 10^9/L Standard Deviation 42.58
Value of Haematology Blood Tests to Detect Change From Baseline Platelets - Week 52	28.0 10^9/L Standard Deviation 74.28	46.1 10^9/L Standard Deviation 74.91	6.6 10^9/L Standard Deviation 64.24	-2.0 10^9/L Standard Deviation 33.85
Value of Haematology Blood Tests to Detect Change From Baseline Platelets - Week 60	-19.1 10^9/L Standard Deviation 53.48	39.0 10^9/L Standard Deviation 60.33	24.4 10^9/L Standard Deviation 65.73	-2.8 10^9/L Standard Deviation 28.43

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline in protein-creatinine ratio urinalysis tests are reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline Protein/Creatinine - Week 12	1.37029 g/g Standard Deviation 5.186672	-0.13007 g/g Standard Deviation 1.123807	-0.03056 g/g Standard Deviation 0.056701	0.32764 g/g Standard Deviation 0.337631
Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline Protein/Creatinine - Week 52	0.03756 g/g Standard Deviation 0.135157	-0.00465 g/g Standard Deviation 0.183327	-0.00781 g/g Standard Deviation 0.047671	0.080930 g/g Standard Deviation 1.581772
Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline Protein/Creatinine - Week 60	0.02578 g/g Standard Deviation 0.119862	-0.28836 g/g Standard Deviation 1.185347	-0.03501 g/g Standard Deviation 0.061888	0.46178 g/g Standard Deviation 0.899886

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline in total protein urinalysis tests are reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Total Protein Urinalysis Test to Detect Change From Baseline Protein, Total - Week 12	0.7669 g/L Standard Deviation 2.71221	-0.0744 g/L Standard Deviation 0.76445	0 g/L Standard Deviation 0	0.3443 g/L Standard Deviation 0.34301
Value of Total Protein Urinalysis Test to Detect Change From Baseline Protein, Total - Week 52	-0.0029 g/L Standard Deviation 0.08124	-0.0011 g/L Standard Deviation 0.33468	0 g/L Standard Deviation 0	0.1143 g/L Standard Deviation 0.24476
Value of Total Protein Urinalysis Test to Detect Change From Baseline Protein, Total - Week 60	0.1151 g/L Standard Deviation 0.12514	-0.1790 g/L Standard Deviation 0.83066	0.003 g/L Standard Deviation 0.00671	0.3975 g/L Standard Deviation 0.82602

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Alanine Aminotransferase - Week 60	-0.01297 ukat/L Standard Deviation 0.043131	0.09446 ukat/L Standard Deviation 0.365981	-0.04334 ukat/L Standard Deviation 0.032495	-0.01667 ukat/L Standard Deviation 0.18127
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Aspartate Aminotransferase - Week 12	-0.01154 ukat/L Standard Deviation 0.065765	-0.10502 ukat/L Standard Deviation 0.169099	0.00417 ukat/L Standard Deviation 0.059911	0.03334 ukat/L Standard Deviation 0.105430
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Aspartate Aminotransferase - Week 52	-0.04834 ukat/L Standard Deviation 0.066424	-0.05304 ukat/L Standard Deviation 0.196369	0.00333 ukat/L Standard Deviation 0.090847	0.09169 ukat/L Standard Deviation 0.100482
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Aspartate Aminotransferase - Week 60	-0.01111 ukat/L Standard Deviation 0.058937	0.04816 ukat/L Standard Deviation 0.123752	0 ukat/L Standard Deviation 0.050010	-0.02501 ukat/L Standard Deviation 0.099555
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Alanine Aminotransferase - Week 12	0.00769 ukat/L Standard Deviation 0.147479	-0.13003 ukat/L Standard Deviation 0.431764	-0.05418 ukat/L Standard Deviation 0.045905	0.02501 ukat/L Standard Deviation 0.134397
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Alanine Aminotransferase - Week 52	-0.06335 ukat/L Standard Deviation 0.119642	-0.05607 ukat/L Standard Deviation 0.556152	-0.06335 ukat/L Standard Deviation 0.047735	0.04167 ukat/L Standard Deviation 0.169182

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline in clinical creatinine chemistry blood tests (serum) are reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=5 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=4 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Creatinine - Week 12	4.385 umol/L Standard Deviation 8.5799	-3.6 umol/L Standard Deviation 11.2467	5.5 umol/L Standard Deviation 6.3509	5.25 umol/L Standard Deviation 9.8446
Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Creatinine - Week 52	12.2 umol/L Standard Deviation 33.2597	-7.273 umol/L Standard Deviation 19.5862	0.2 umol/L Standard Deviation 13.9714	2.5 umol/L Standard Deviation 5.5076
Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) Creatinine - Week 60	7.316 umol/L Standard Deviation 8.7449	-5.556 umol/L Standard Deviation 12.8463	5.0 umol/L Standard Deviation 10.4163	6.5 umol/L Standard Deviation 12.5033

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).

Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=14 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline ESR - Week 12	-3.0 mm Standard Deviation 20.37	-7.2 mm Standard Deviation 15.46	-11.9 mm Standard Deviation 15.36	—
Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline ESR - Week 52	5.6 mm Standard Deviation 25.58	-6.7 mm Standard Deviation 12.25	-16.0 mm Standard Deviation 10.95	—
Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline ESR - Week 60	14.6 mm Standard Deviation 38.77	-1.0 mm Standard Deviation 21.84	2.2 mm Standard Deviation 22.48	—

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). Only participants with abnormal baseline values are included in this analysis.

Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.

Outcome measures

Measure	Anifrolumab - Lower Dose n=9 Participants 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=8 Participants 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=3 Participants Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50	Placebo Comparator to Higher Dose n=3 Participants Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50
Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline anti-dsDNA - Week 12	-42.09 IU/mL Standard Deviation 256.228	-84.97 IU/mL Standard Deviation 231.489	-37.0 IU/mL Standard Deviation 19.799	-97.33 IU/mL Standard Deviation 151.596
Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline anti-dsDNA - Week 52	-99.04 IU/mL Standard Deviation 288.183	8.70 IU/mL Standard Deviation 27.308	-13.0 IU/mL Standard Deviation 50.229	-76.87 IU/mL Standard Deviation 127.433
Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline anti-dsDNA - Week 60	52.67 IU/mL Standard Deviation 144.220	16.53 IU/mL Standard Deviation 30.528	-21.33 IU/mL Standard Deviation 54.921	-76.73 IU/mL Standard Deviation 141.525

SECONDARY outcome

Timeframe: Baseline to Week 60

Population: Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). No participants were positive for Hepatitis B at screening, therefore no participants were tested post-baseline.

Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.

Outcome measures

Outcome data not reported

Adverse Events

Anifrolumab - Lower Dose

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Anifrolumab - Higher Dose

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Comparator

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anifrolumab - Lower Dose n=14 participants at risk 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 participants at risk 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 participants at risk Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
Infections and infestations Herpes Zoster	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Otitis Media Acute	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Nervous system disorders Transient Ischaemic Attack	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Mouth Ulceration	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Musculoskeletal and connective tissue disorders Systemic Lupus Erythematosus	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Renal and urinary disorders Lupus Nephritis	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.

Other adverse events

Measure	Anifrolumab - Lower Dose n=14 participants at risk 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50	Anifrolumab - Higher Dose n=13 participants at risk 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50	Placebo Comparator n=9 participants at risk Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50
Infections and infestations Abscess Limb	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Acute Sinusitis	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Bronchitis	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	23.1% 3/13 • Number of events 5 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Conjunctivitis	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Conjunctivitis Viral	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Herpes Zoster	14.3% 2/14 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Influenza	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Labyrinthitis	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Laryngitis	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Nasopharyngitis	21.4% 3/14 • Number of events 3 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	15.4% 2/13 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Pharyngitis	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Sinusitis	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Upper Respiratory Tract Infection	35.7% 5/14 • Number of events 9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	33.3% 3/9 • Number of events 3 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Infections and infestations Urinary Tract Infection	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Blood and lymphatic system disorders Anaemia	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Immune system disorders Hypersensitivity	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Psychiatric disorders Panic Attack	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Nervous system disorders Headache	14.3% 2/14 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	15.4% 2/13 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Nervous system disorders Hypoaesthesia	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Nervous system disorders Migraine	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Nervous system disorders Sciatica	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	15.4% 2/13 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Nervous system disorders Syncope	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Eye disorders Chalazion	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Eye disorders Myopia	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Eye disorders Uveitis	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Cardiac disorders Atrial Fibrillation	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Cardiac disorders Palpitations	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Cardiac disorders Pericardial Cyst	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Vascular disorders Hypertension	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Respiratory, thoracic and mediastinal disorders Nasal Inflammation	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Respiratory, thoracic and mediastinal disorders Nasal Septum Perforation	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Respiratory, thoracic and mediastinal disorders Productive Cough	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Abdominal Discomfort	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Abdominal Pain	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Dental Caries	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	22.2% 2/9 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Food Poisoning	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Haemorrhoids	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Mouth Ulceration	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Gastrointestinal disorders Paraesthesia Oral	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Skin and subcutaneous tissue disorders Angioedema	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Skin and subcutaneous tissue disorders Miliaria	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Skin and subcutaneous tissue disorders Urticaria	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Musculoskeletal and connective tissue disorders Back Pain	14.3% 2/14 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Musculoskeletal and connective tissue disorders Spinal Pain	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Renal and urinary disorders Dysuria	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Renal and urinary disorders Proteinuria	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Renal and urinary disorders Renal Impairment	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Pregnancy, puerperium and perinatal conditions Anembryonic Gestation	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Reproductive system and breast disorders Endometrial Hyperplasia	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
General disorders Chest Pain	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
General disorders Face Oedema	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 2 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
General disorders Feeling Hot	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
General disorders Oedema Peripheral	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
General disorders Pain	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
General disorders Pyrexia	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	11.1% 1/9 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Investigations Mycobacterium Tuberculosis Complex Test Positive	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Injury, poisoning and procedural complications Foot Fracture	7.1% 1/14 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/13 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Injury, poisoning and procedural complications Subcutaneous Haematoma	0.00% 0/14 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	7.7% 1/13 • Number of events 1 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.	0.00% 0/9 • 52 weeks An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.

Additional Information

Global Clinical Lead

AstraZeneca AB

Phone: 301-398-5799

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60