Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304 (NCT NCT02656303)

NCT ID: NCT02656303

Last Updated: 2023-06-22

Results Overview

ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters (cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolute neutrophil count(ANC)\>1.5x10\^9/L,platelets≥100x10\^9/L,hemoglobin (Hgb)≥110 gram per liter(g/L). PR: No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC\<4x10\^9/L or ≥50% decrease from baseline in sum of products(SPD) of target nodal lesions; splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; response in any 1:ANC\>1.5x10\^9/L,platelets\>100x10\^9/L,Hgb\>110g/L or ≥50% increase over baseline in any of these.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 116 participants
• Primary outcome timeframe: Up to 76 months
• Results posted on: 2023-06-22

Participant Flow

A total of 116 participants took part across 50 investigative sites in the United States, United Kingdom, Italy, and Poland from 07 January 2016 to 11 July 2022.

Participant milestones

Measure	Parent Study Arm B Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm C Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm D Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Overall Study STARTED	67	31	18
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	67	31	18

Reasons for withdrawal

Measure	Parent Study Arm B Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm C Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm D Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Overall Study Adverse Event	3	2	0
Overall Study Death	12	4	1
Overall Study Lack of Efficacy	1	0	0
Overall Study Non-Compliance with Study	1	1	0
Overall Study Investigator Decision	2	1	0
Overall Study Progressive Disease	25	14	10
Overall Study Study Terminated by Sponsor	20	7	5
Overall Study Withdrawal of Consent by Participants	1	1	0
Overall Study Initiation of Non-protocol Intervention	1	0	0
Overall Study Reason not Specified	1	1	2

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

Baseline characteristics by cohort

Measure	Parent Study Arm B n=67 Participants Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm C n=31 Participants Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm D n=18 Participants Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Total n=116 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 8.18 • n=5 Participants	66.7 years STANDARD_DEVIATION 9.41 • n=7 Participants	65.7 years STANDARD_DEVIATION 8.79 • n=5 Participants	65.9 years STANDARD_DEVIATION 8.55 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	26 Participants n=7 Participants	13 Participants n=5 Participants	87 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	30 Participants n=7 Participants	16 Participants n=5 Participants	112 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	65 Participants n=5 Participants	30 Participants n=7 Participants	15 Participants n=5 Participants	110 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 76 months

Population: Data for this outcome measure was not collected or analyzed as the study was terminated due to sponsor's business decision.

ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters (cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolute neutrophil count(ANC)>1.5x10^9/L,platelets≥100x10^9/L,hemoglobin (Hgb)≥110 gram per liter(g/L). PR: No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or ≥50% decrease from baseline in sum of products(SPD) of target nodal lesions; splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; response in any 1:ANC>1.5x10^9/L,platelets>100x10^9/L,Hgb>110g/L or ≥50% increase over baseline in any of these.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 76 months

Population: Data for this outcome measure was not collected or analyzed as the study was terminated due to sponsor's business decision.

The CR rate was defined as the percentage of participants who achieved CR. CR: No evidence of new disease; ALC <4 x 10^9/L; Regression of all target nodal masses to normal size ≤1.5 cm in the LD; Normal spleen and liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC >1.5 x 10^9/L, platelets ≥100 x 10^9/L, Hgb ≥110 g/L.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 76 months

Population: Data for this outcome measure was not collected or analyzed as the study was terminated due to sponsor's business decision.

PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes >1.5 cm in the LD and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 g/L decrease from the highest on-study Hgb.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 76 months

Population: Data for this outcome measure was not collected or analyzed as the study was terminated due to sponsor's business decision.

DOR:Interval from first documentation of CR/PR to first documentation of PD or death from any cause.CR:ALC<4x10^9/L;Regression to normal of target nodal masses,nodal non-target disease,and no detectable non-nodal,non-target disease;Normal spleen,liver size;Morphologically negative bone marrow,No lymphoid nodules;ANC>1.5x10^9/L,Platelets≥100x10^9/L,Hgb≥110 g/L.PR:Response in 2 or more:ALC<4x10^9/L, ≥50% drop from baseline in ALC or SPD of target nodal lesions,Hepatosplenomegaly,≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;Response in 1 or more:ANC>1.5x10^9/L,Platelets>100x10^9/L,Hgb>110 g/L or ≥50% increase over baseline in any.PD:Response in 1 or more:new nodes,Hepatosplenomegaly,unequivocal extra-nodal lesion;≥50% increase from nadir in SPD of target lesions or LD of node/extra-nodal mass or Splenic/Hepatic size,Unequivocal increase in non-target disease,More aggressive histology;Drop of >50% in platelets/>20g/L in Hgb from highest on-study count.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Cycle 6 until Cycle 15 (cycle length=28 days) (Up to approximately 76 months)

Population: Data for this outcome measure was not collected or analyzed as the study was terminated due to sponsor's business decision.

MRD negativity rate is defined as the percentage of participants who are MRD negative. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 78 months

Population: The Safety Population included all participants who were enrolled and received at least one dose of study drug.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related.

Outcome measures

Measure	Parent Study Arm B n=67 Participants Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm C n=31 Participants Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm D n=18 Participants Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)	66 Participants	30 Participants	18 Participants

Adverse Events

Parent Study Arm B

Serious events: 36 serious events

Other events: 65 other events

Deaths: 23 deaths

Parent Study Arm C

Serious events: 13 serious events

Other events: 30 other events

Deaths: 9 deaths

Parent Study Arm D

Serious events: 8 serious events

Other events: 17 other events

Deaths: 7 deaths

Serious adverse events

Measure	Parent Study Arm B n=67 participants at risk Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm C n=31 participants at risk Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm D n=18 participants at risk Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Lymph node haemorrhage	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Colitis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Enterocolitis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Chest pain	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Death	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Malaise	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Pyrexia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Sudden cardiac death	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Immune system disorders Anaphylactic shock	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Aspergillus infection	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Babesiosis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Bronchitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations COVID-19	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Cytomegalovirus infection	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Pneumocystis jirovecii pneumonia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Pneumonia	11.9% 8/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Rectal abscess	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Respiratory tract infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Sepsis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Septic shock	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Overdose	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Radius fracture	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood creatinine increased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Cerebral infarction	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Ischaemic stroke	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Paraparesis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Reproductive system and breast disorders Prostatitis	2.1% 1/48 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/26 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/13 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Hypertension	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.

Other adverse events

Measure	Parent Study Arm B n=67 participants at risk Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm C n=31 participants at risk Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.	Parent Study Arm D n=18 participants at risk Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Injury, poisoning and procedural complications Fall	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Fracture	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	22.4% 15/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.1% 5/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	50.0% 9/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Limb injury	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Overdose	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Skin laceration	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Skin wound	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Upper limb fracture	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Vaccination complication	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Wound	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	20.9% 14/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	29.0% 9/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	22.2% 4/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Urinary tract infection	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	11.9% 8/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Increased tendency to bruise	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Leukocytosis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	25.4% 17/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	19.4% 6/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	33.3% 6/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Atrial flutter	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Bradycardia	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Myocardial infarction	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Palpitations	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Pericardial effusion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Tachyarrhythmia	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Tachycardia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Congenital, familial and genetic disorders Hydrocele	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Deafness	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Deafness unilateral	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Ear pain	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Hyperacusis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Hypoacusis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Inner ear inflammation	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Meniere's disease	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Middle ear inflammation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Tinnitus	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Vertigo positional	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Endocrine disorders Adrenal insufficiency	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Age-related macular degeneration	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Blepharitis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Chalazion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Conjunctival haemorrhage	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Dry eye	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Eye irritation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Eye swelling	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Lacrimation increased	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Ocular hyperaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Vision blurred	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Visual brightness	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.1% 5/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain lower	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal tenderness	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Colitis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Constipation	16.4% 11/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	52.2% 35/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	35.5% 11/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	33.3% 6/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	13.4% 9/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Eructation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Faeces soft	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Flatulence	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Gastric dilatation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Gastric polyps	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Gastritis	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Haematochezia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Hiatus hernia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Nausea	43.3% 29/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	32.3% 10/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	27.8% 5/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Oral pain	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Tongue discomfort	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Tongue ulceration	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Vomiting	16.4% 11/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Adverse drug reaction	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Asthenia	16.4% 11/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Axillary pain	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Catheter site erythema	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Chest discomfort	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Chills	19.4% 13/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Face oedema	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Fatigue	34.3% 23/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	38.7% 12/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Feeling abnormal	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Feeling cold	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Gait disturbance	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Hypothermia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Localised oedema	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Malaise	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Non-cardiac chest pain	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Oedema peripheral	20.9% 14/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	19.4% 6/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.7% 3/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Peripheral swelling	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Pyrexia	20.9% 14/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	22.2% 4/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Secretion discharge	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Swelling	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
General disorders Swelling face	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Hypertransaminasaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Immune system disorders Allergy to arthropod bite	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Immune system disorders Contrast media allergy	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Immune system disorders Hypogammaglobulinaemia	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Immune system disorders Seasonal allergy	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Body tinea	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Bronchitis	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations COVID-19	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Campylobacter infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Candida infection	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Chronic sinusitis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Conjunctivitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Cystitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Cytomegalovirus infection	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Cytomegalovirus infection reactivation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Diverticulitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Ear infection	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Epididymitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Folliculitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Fungal oesophagitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Fungal skin infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Gingivitis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Herpes zoster	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Hordeolum	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Influenza	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Laryngitis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Mastoiditis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Mycobacterium avium complex infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Nasopharyngitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Otitis media	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Pharyngitis streptococcal	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Pneumonia	17.9% 12/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	22.2% 4/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Pseudomonas infection	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Respiratory tract infection	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Rhinitis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Rhinovirus infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Sepsis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Sinusitis	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Skin infection	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Tooth abscess	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Tooth infection	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Wrist fracture	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Alanine aminotransferase increased	22.4% 15/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	19.4% 6/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.7% 3/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	22.4% 15/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	10.4% 7/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood bicarbonate decreased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood bilirubin increased	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood creatinine increased	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood lactate dehydrogenase increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood potassium decreased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood pressure increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood sodium decreased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood urea increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood uric acid increased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood urine present	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Cardiac murmur	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Glomerular filtration rate decreased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Haematocrit increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Haemoglobin decreased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Lymphocyte count increased	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Monocyte percentage decreased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Neutrophil count decreased	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	27.8% 5/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Neutrophil percentage decreased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Platelet count decreased	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Prostatic specific antigen increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations SARS-CoV-2 test positive	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Urine output decreased	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Weight decreased	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations Weight increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations White blood cell count decreased	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Investigations White blood cell count increased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	14.9% 10/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.7% 3/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Food intolerance	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	13.4% 9/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Iron deficiency	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Obesity	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 12/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	17.9% 12/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Gouty arthritis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Groin pain	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint effusion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle tightness	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle twitching	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteopenia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.7% 3/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Ataxia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Cognitive disorder	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Dementia	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Disturbance in attention	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Dizziness	17.9% 12/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Drooling	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Dysaesthesia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Dysgeusia	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Essential tremor	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Head discomfort	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Headache	14.9% 10/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Hyperaesthesia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Memory impairment	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Myoclonus	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Nervous system disorder	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Restless legs syndrome	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Sciatica	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Seizure	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Slow speech	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Somnolence	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Syncope	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Tremor	11.9% 8/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Abnormal dreams	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Agitation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Anxiety	10.4% 7/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Confusional state	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Delirium	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Depression	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Hallucination	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Insomnia	23.9% 16/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.1% 5/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.7% 3/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Mental status changes	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Mood altered	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Personality change	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Restlessness	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Somatic symptom disorder	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Chromaturia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Chronic kidney disease	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Dysuria	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Haematuria	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Micturition urgency	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Nocturia	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Pollakiuria	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Polyuria	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Renal colic	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Renal cyst	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Renal failure	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Urinary incontinence	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Urinary retention	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Urinary tract pain	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Reproductive system and breast disorders Cervical dysplasia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Reproductive system and breast disorders Haematospermia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Reproductive system and breast disorders Pelvic discomfort	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Reproductive system and breast disorders Prostatomegaly	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Reproductive system and breast disorders Testicular oedema	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Choking	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	32.8% 22/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.1% 5/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.7% 3/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.9% 10/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	16.7% 3/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Increased viscosity of upper respiratory secretion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung infiltration	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung opacity	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.0% 4/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rales	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory tract irritation	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	7.5% 5/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat tightness	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia areata	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ingrowing nail	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Miliaria	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	10.4% 7/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Onychoclasis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Precancerous skin lesion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	10.4% 7/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash pruritic	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin erosion	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin irritation	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Surgical and medical procedures Pleurodesis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Aortic stenosis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Arteriosclerosis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Flushing	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Hot flush	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Hypertension	9.0% 6/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	11.1% 2/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Hypotension	4.5% 3/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Pallor	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Thrombophlebitis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Thrombosis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Varicose vein	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Enterocolitis	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	5.6% 1/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Babesiosis	1.5% 1/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Oral herpes	3.0% 2/67 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/18 • Up to approximately 78 months The Safety Population included all participants who were enrolled and received at least one dose of study drug.

Additional Information

TG Therapeutics Clinical Support Team

TG Therapeutics

Phone: 1-877-575-8489

Email: clinicalsupport@tgtxinc.com

Results disclosure agreements

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