Trial Outcomes & Findings for Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026) (NCT NCT03547154)

NCT ID: NCT03547154

Last Updated: 2019-08-12

Results Overview

Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph\^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH\^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (\>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 344 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2019-08-12

Participant Flow

Participant milestones

Measure	INTRON A (Interferon Alfa-2b) Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity.	PEG Intron (Pegylated Interferon Alfa-2b) Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Overall Study STARTED	173	171
Overall Study COMPLETED	50	55
Overall Study NOT COMPLETED	123	116

Reasons for withdrawal

Measure	INTRON A (Interferon Alfa-2b) Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity.	PEG Intron (Pegylated Interferon Alfa-2b) Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Overall Study Disease Progression/Recurrence	6	14
Overall Study Adverse Event	26	31
Overall Study Protocol Violation	6	1
Overall Study Physician Decision	4	3
Overall Study Insufficient Therapeutic Response	13	10
Overall Study Withdrawal by Subject	10	6
Overall Study Not Selected	0	1
Overall Study Continued treatment beyond 12 mo.	58	50

Baseline Characteristics

Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)

Baseline characteristics by cohort

Measure	INTRON A (Interferon Alfa-2b) n=173 Participants Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.	PEG Intron (Pegylated Interferon Alfa-2b) n=171 Participants Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.	Total n=344 Participants Total of all reporting groups
Age, Continuous	51.6 Years STANDARD_DEVIATION 13.4 • n=5 Participants	51.9 Years STANDARD_DEVIATION 12.8 • n=7 Participants	51.7 Years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	75 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	96 Participants n=7 Participants	202 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: All randomized participants analyzed on an intent-to-treat basis.

Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.

Outcome measures

Measure	INTRON A (Interferon Alfa-2b) n=173 Participants Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.	PEG Intron (Pegylated Interferon Alfa-2b) n=171 Participants Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months Complete Response	13 Participants	13 Participants
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months Discontinued or No Hematologic CR at Month 6	78 Participants	83 Participants
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months Participants with Missing Data	1 Participants	0 Participants
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months Partial Response	35 Participants	26 Participants
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months Minor Respnse	31 Participants	24 Participants
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months No Respnse	15 Participants	25 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All randomized participants who received at least one dose of assigned treatment

Cytogenetic response (CR) at 6 months, as at 12 months, was defined by the degree of suppression of Philadelphia chromosome (Ph^1) achieved during study treatment. The determination of CR at 6 months was based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH^1-positive cells during study treatment. Protocol-defined CR criteria were Complete (0%), Partial (1-34%), Minor (35-90%), or No Response (>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.

Outcome measures

Measure	INTRON A (Interferon Alfa-2b) n=173 Participants Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.	PEG Intron (Pegylated Interferon Alfa-2b) n=171 Participants Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months Minor Response: 35-90% Ph+	51 Participants	37 Participants
Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months Complete Response: 0% Ph+	7 Participants	3 Participants
Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months Partial Response: 1-34% Ph+	19 Participants	23 Participants
Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months No Response: >90% Ph+	48 Participants	61 Participants
Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months Participant with Missing Data	48 Participants	47 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All randomized participants who received at least one dose of assigned treatment

Hematologic response at 6 months was assessed, while the hematologic response was measured at 3, 6, 9 and 12 months during the first year of study treatment. To be considered a hematologic responder a participant must have met all of the following criteria for a minimum of 28 days: WBC count <10,000/μL; platelet count <450,000/L; normal differential count in peripheral blood (manual differential count); no palpable spleen. Participants achieving a complete hematologic response at 3 months had the cytogenetic response evaluated at 3 months as well. Participants who achieved a complete hematologic response by 6 months continued treatment for another 6 months. Participants who failed to achieve a complete hematologic response after 6 months of treatment were considered treatment failures, and further treatment for this group was at the discretion of the treating physician. Participants may have continued to receive their assigned study medication for an additional 6 months.

Outcome measures

Measure	INTRON A (Interferon Alfa-2b) n=173 Participants Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.	PEG Intron (Pegylated Interferon Alfa-2b) n=171 Participants Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months Missing	31 Participants	28 Participants
Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months Complete Response	98 Participants	91 Participants
Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months Treatment Failure	44 Participants	52 Participants

SECONDARY outcome

Timeframe: Up to 2 years (24 months), and beyond

Population: All randomized participants who received at least one dose of assigned treatment

Participants were followed for survival; those who did not achieve a major cytogenetic response were discontinued from the study. For participants who completed 1 year of study treatment and continued to Year 2 and beyond, survival and disease progression every 3 months were assessed, and serious adverse events (SAEs) were reported. Participants were followed until resolution of any drug-related nonserious adverse event, and any SAE occurring while on the study or within 30 days of last dose of study drug. Participant death during survival follow-up was reported to the drug safety unit of the Sponsor. Each participant (whether discontinued or still on treatment) was followed every 3 months for survival and disease progression information. Overall survival was analyzed using the log-rank statistic, and the hazard ratio (HR) and 95% confidence interval (CI) for the HR were obtained using Cox's proportional hazards model.

Outcome measures

Measure	INTRON A (Interferon Alfa-2b) n=173 Participants Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.	PEG Intron (Pegylated Interferon Alfa-2b) n=171 Participants Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Number of Participants With Overall Survival Deaths	15 Participants	17 Participants
Number of Participants With Overall Survival Survivors	158 Participants	154 Participants

Adverse Events

INTRON A, 5 MIU/m^2 Daily

Serious events: 62 serious events

Other events: 170 other events

Deaths: 15 deaths

PEG-Intron, 6.0 mcg/kg Weekly

Serious events: 74 serious events

Other events: 168 other events

Deaths: 17 deaths

Serious adverse events

Measure	INTRON A, 5 MIU/m^2 Daily n=173 participants at risk Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity.	PEG-Intron, 6.0 mcg/kg Weekly n=171 participants at risk Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders PLEURISY	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	2.3% 4/171 • Number of events 4 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders HAEMOLYTIC ANAEMIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders HYPERGAMMAGLOBULINAEMIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders LEUKOPENIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders NEUTROPENIA	1.7% 3/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	2.3% 4/173 • Number of events 4 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders ANGINA PECTORIS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders ATRIAL FIBRILLATION	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders BRADYCARDIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders CYANOSIS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders PALPITATIONS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders TACHYARRHYTHMIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Ear and labyrinth disorders VERTIGO	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Endocrine disorders HYPERTHYROIDISM	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Eye disorders OCULAR TOXICITY	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Eye disorders VISUAL ACUITY REDUCED	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders ABDOMINAL PAIN	1.2% 2/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders DIARRHOEA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders DUODENITIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders DYSPHAGIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders GASTRITIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders HIATUS HERNIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders INGUINAL HERNIA	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders NAUSEA	1.7% 3/173 • Number of events 4 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	3.5% 6/171 • Number of events 6 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders VOMITING	2.3% 4/173 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders ASTHENIA	1.2% 2/173 • Number of events 4 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders CHEST PAIN	1.7% 3/173 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	2.9% 5/171 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders CHILLS	1.2% 2/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders FATIGUE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders HERNIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders HYPERTHERMIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders HYPOTHERMIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders MALAISE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders PYREXIA	3.5% 6/173 • Number of events 8 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	4.1% 7/171 • Number of events 8 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Hepatobiliary disorders CHOLELITHIASIS	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Hepatobiliary disorders CYTOLYTIC HEPATITIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Hepatobiliary disorders HEPATOMEGALY	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Hepatobiliary disorders HEPATOTOXICITY	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Hepatobiliary disorders JAUNDICE	0.58% 1/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations APPENDICITIS	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations BRONCHOPNEUMONIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations CELLULITIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations FUNGAL INFECTION	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations GASTROENTERITIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations HERPES ZOSTER	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations INFECTED CYST	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations INFECTION	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations INJECTION SITE ABSCESS	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations NEUTROPENIC SEPSIS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations PHARYNGITIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations PNEUMONIA	1.7% 3/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations RESPIRATORY TRACT INFECTION	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations SEPSIS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations STAPHYLOCOCCAL ABSCESS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations URINARY TRACT INFECTION	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations UROSEPSIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Injury, poisoning and procedural complications JOINT INJURY	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations ALANINE AMINOTRANSFERASE ABNORMAL	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations ALANINE AMINOTRANSFERASE INCREASED	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 6 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations BLOOD BILIRUBIN INCREASED	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations BODY TEMPERATURE INCREASED	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations HEPATIC ENZYME INCREASED	1.2% 2/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations HEPATITIS B VIRUS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations LABORATORY TEST ABNORMAL	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations TRANSAMINASES INCREASED	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations WEIGHT DECREASED	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders ANOREXIA	1.2% 2/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders CELL DEATH	0.58% 1/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders DEHYDRATION	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders HYPOGLYCAEMIA	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.7% 3/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	4.1% 7/171 • Number of events 7 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.58% 1/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MYALGIA	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	2.9% 5/171 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLAST CELL CRISIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLAST CRISIS IN MYELOGENOUS LEUKAEMIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-HODGKIN'S LYMPHOMA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NEOPLASM	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders CEREBRAL ISCHAEMIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders COMA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders CONVULSION	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders DIZZINESS	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	2.3% 4/171 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders EPILEPSY	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders GRAND MAL CONVULSION	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders HEADACHE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders PARAESTHESIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders PARESIS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders SCIATICA	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders SOMNOLENCE	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders STATUS EPILEPTICUS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders SYNCOPE	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders SYNCOPE VASOVAGAL	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders ANXIETY	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders COMPLETED SUICIDE	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders CONFUSIONAL STATE	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders DEPRESSION	1.7% 3/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders INSOMNIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders SUICIDAL IDEATION	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Reproductive system and breast disorders CYSTOCELE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders COUGH	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.7% 3/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	2.3% 4/171 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders PRURITUS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders PSORIASIS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders RASH	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.58% 1/173 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Vascular disorders AORTIC ANEURYSM	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.00% 0/171 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Vascular disorders CIRCULATORY COLLAPSE	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Vascular disorders HYPOTENSION	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.2% 2/171 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Vascular disorders VENA CAVA THROMBOSIS	0.00% 0/173 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	0.58% 1/171 • Number of events 1 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.

Other adverse events

Measure	INTRON A, 5 MIU/m^2 Daily n=173 participants at risk Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity.	PEG-Intron, 6.0 mcg/kg Weekly n=171 participants at risk Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders ANAEMIA	4.6% 8/173 • Number of events 10 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	12.3% 21/171 • Number of events 43 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders LEUKOPENIA	11.0% 19/173 • Number of events 32 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	11.1% 19/171 • Number of events 38 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders LYMPHADENOPATHY	3.5% 6/173 • Number of events 7 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.6% 13/171 • Number of events 13 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders NEUTROPENIA	5.2% 9/173 • Number of events 11 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.0% 12/171 • Number of events 29 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	20.2% 35/173 • Number of events 65 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	19.9% 34/171 • Number of events 74 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Cardiac disorders PALPITATIONS	1.7% 3/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 18 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Ear and labyrinth disorders EAR PAIN	4.0% 7/173 • Number of events 63 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Ear and labyrinth disorders TINNITUS	3.5% 6/173 • Number of events 9 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	6.4% 11/171 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Ear and labyrinth disorders VERTIGO	12.7% 22/173 • Number of events 36 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	13.5% 23/171 • Number of events 61 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Eye disorders CONJUNCTIVITIS	3.5% 6/173 • Number of events 6 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 15 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Eye disorders EYE PAIN	6.9% 12/173 • Number of events 42 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	4.7% 8/171 • Number of events 25 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Eye disorders VISION BLURRED	6.4% 11/173 • Number of events 14 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.6% 13/171 • Number of events 16 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders ABDOMINAL PAIN	19.1% 33/173 • Number of events 59 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	22.8% 39/171 • Number of events 105 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	25.4% 44/173 • Number of events 108 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	29.8% 51/171 • Number of events 169 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders APHTHOUS STOMATITIS	5.8% 10/173 • Number of events 15 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	4.1% 7/171 • Number of events 8 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders CONSTIPATION	22.0% 38/173 • Number of events 130 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	21.1% 36/171 • Number of events 89 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders DIARRHOEA	54.9% 95/173 • Number of events 314 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	60.8% 104/171 • Number of events 503 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders DRY MOUTH	35.3% 61/173 • Number of events 157 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	33.3% 57/171 • Number of events 179 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders DYSPEPSIA	13.3% 23/173 • Number of events 28 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	10.5% 18/171 • Number of events 33 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders GASTRITIS	5.2% 9/173 • Number of events 14 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders GINGIVAL BLEEDING	1.2% 2/173 • Number of events 2 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 14 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders NAUSEA	58.4% 101/173 • Number of events 429 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	64.9% 111/171 • Number of events 627 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders ORAL PAIN	1.2% 2/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.0% 12/171 • Number of events 38 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders STOMACH DISCOMFORT	9.2% 16/173 • Number of events 86 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.6% 13/171 • Number of events 51 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders STOMATITIS	7.5% 13/173 • Number of events 16 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.3% 9/171 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders TOOTHACHE	4.6% 8/173 • Number of events 11 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.3% 9/171 • Number of events 11 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Gastrointestinal disorders VOMITING	30.6% 53/173 • Number of events 108 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	36.3% 62/171 • Number of events 178 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders ASTHENIA	46.8% 81/173 • Number of events 246 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	55.0% 94/171 • Number of events 400 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders CHEST PAIN	15.0% 26/173 • Number of events 68 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	15.2% 26/171 • Number of events 75 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders CHILLS	62.4% 108/173 • Number of events 254 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	67.3% 115/171 • Number of events 377 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders FATIGUE	60.7% 105/173 • Number of events 637 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	60.2% 103/171 • Number of events 929 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders FEELING COLD	5.2% 9/173 • Number of events 12 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	3.5% 6/171 • Number of events 24 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders GAIT DISTURBANCE	4.0% 7/173 • Number of events 7 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.0% 12/171 • Number of events 25 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders INFLUENZA LIKE ILLNESS	4.0% 7/173 • Number of events 10 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 22 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders INJECTION SITE ERYTHEMA	9.8% 17/173 • Number of events 19 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	21.6% 37/171 • Number of events 80 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders INJECTION SITE PAIN	11.0% 19/173 • Number of events 31 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	11.7% 20/171 • Number of events 35 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders INJECTION SITE RASH	2.9% 5/173 • Number of events 7 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	6.4% 11/171 • Number of events 18 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders INJECTION SITE REACTION	3.5% 6/173 • Number of events 7 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	10.5% 18/171 • Number of events 48 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders IRRITABILITY	8.1% 14/173 • Number of events 34 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.3% 9/171 • Number of events 18 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders MALAISE	11.0% 19/173 • Number of events 45 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	15.8% 27/171 • Number of events 180 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders OEDEMA PERIPHERAL	6.4% 11/173 • Number of events 13 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	10.5% 18/171 • Number of events 28 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders PAIN	28.3% 49/173 • Number of events 135 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	28.1% 48/171 • Number of events 236 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders PYREXIA	76.9% 133/173 • Number of events 468 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	82.5% 141/171 • Number of events 1121 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
General disorders THIRST	2.3% 4/173 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.0% 12/171 • Number of events 16 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations BRONCHITIS	7.5% 13/173 • Number of events 20 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	11.1% 19/171 • Number of events 25 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations NASOPHARYNGITIS	10.4% 18/173 • Number of events 21 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	14.0% 24/171 • Number of events 56 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations ORAL HERPES	2.9% 5/173 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	6.4% 11/171 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations PHARYNGITIS	3.5% 6/173 • Number of events 9 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 12 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations RHINITIS	5.2% 9/173 • Number of events 9 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.3% 9/171 • Number of events 13 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations SINUSITIS	5.8% 10/173 • Number of events 12 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.3% 9/171 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.8% 10/173 • Number of events 12 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.6% 13/171 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Infections and infestations URINARY TRACT INFECTION	4.6% 8/173 • Number of events 10 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	8.8% 15/171 • Number of events 18 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations PLATELET COUNT DECREASED	6.4% 11/173 • Number of events 15 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	6.4% 11/171 • Number of events 19 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations WEIGHT DECREASED	39.9% 69/173 • Number of events 128 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	47.4% 81/171 • Number of events 122 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Investigations WHITE BLOOD CELL COUNT DECREASED	6.4% 11/173 • Number of events 19 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	7.0% 12/171 • Number of events 39 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders ANOREXIA	49.7% 86/173 • Number of events 218 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	60.2% 103/171 • Number of events 315 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Metabolism and nutrition disorders DECREASED APPETITE	13.9% 24/173 • Number of events 52 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	17.0% 29/171 • Number of events 63 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	45.7% 79/173 • Number of events 401 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	50.9% 87/171 • Number of events 474 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	47.4% 82/173 • Number of events 337 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	46.8% 80/171 • Number of events 472 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	13.9% 24/173 • Number of events 93 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	28.1% 48/171 • Number of events 292 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders FLANK PAIN	5.2% 9/173 • Number of events 30 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	4.1% 7/171 • Number of events 10 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	12.1% 21/173 • Number of events 54 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	8.2% 14/171 • Number of events 69 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	9.2% 16/173 • Number of events 25 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	9.9% 17/171 • Number of events 36 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	8.1% 14/173 • Number of events 34 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	9.4% 16/171 • Number of events 20 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	22.0% 38/173 • Number of events 89 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	19.3% 33/171 • Number of events 65 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	4.6% 8/173 • Number of events 14 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	9.4% 16/171 • Number of events 51 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders MYALGIA	63.0% 109/173 • Number of events 416 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	57.9% 99/171 • Number of events 532 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders NECK PAIN	9.2% 16/173 • Number of events 28 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	9.9% 17/171 • Number of events 51 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	37.0% 64/173 • Number of events 304 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	32.7% 56/171 • Number of events 187 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders AGEUSIA	2.3% 4/173 • Number of events 5 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 19 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders AMNESIA	5.8% 10/173 • Number of events 18 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	3.5% 6/171 • Number of events 10 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders DISTURBANCE IN ATTENTION	6.9% 12/173 • Number of events 27 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.3% 9/171 • Number of events 15 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders DIZZINESS	39.3% 68/173 • Number of events 256 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	34.5% 59/171 • Number of events 252 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders DYSGEUSIA	19.7% 34/173 • Number of events 75 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	20.5% 35/171 • Number of events 101 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders HEADACHE	74.0% 128/173 • Number of events 716 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	77.2% 132/171 • Number of events 1362 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders HYPOAESTHESIA	8.1% 14/173 • Number of events 28 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	14.0% 24/171 • Number of events 43 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders PARAESTHESIA	9.8% 17/173 • Number of events 32 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	12.9% 22/171 • Number of events 34 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders SCIATICA	4.0% 7/173 • Number of events 10 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 32 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders SOMNOLENCE	13.9% 24/173 • Number of events 44 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	11.7% 20/171 • Number of events 59 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Nervous system disorders TREMOR	11.6% 20/173 • Number of events 44 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	13.5% 23/171 • Number of events 55 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders ANXIETY	19.1% 33/173 • Number of events 61 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	24.6% 42/171 • Number of events 110 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders DEPRESSED MOOD	1.7% 3/173 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	6.4% 11/171 • Number of events 22 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders DEPRESSION	29.5% 51/173 • Number of events 111 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	33.9% 58/171 • Number of events 131 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Psychiatric disorders INSOMNIA	32.9% 57/173 • Number of events 128 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	28.1% 48/171 • Number of events 150 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Renal and urinary disorders DYSURIA	1.7% 3/173 • Number of events 4 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	5.8% 10/171 • Number of events 12 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders COUGH	39.9% 69/173 • Number of events 122 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	32.7% 56/171 • Number of events 120 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	21.4% 37/173 • Number of events 98 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	22.2% 38/171 • Number of events 89 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	5.2% 9/173 • Number of events 14 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	1.8% 3/171 • Number of events 3 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	8.7% 15/173 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	12.9% 22/171 • Number of events 37 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	6.4% 11/173 • Number of events 17 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	4.1% 7/171 • Number of events 13 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders PHARYNGOLARYNGEAL PAIN	20.8% 36/173 • Number of events 101 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	25.7% 44/171 • Number of events 109 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	11.0% 19/173 • Number of events 36 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	11.7% 20/171 • Number of events 30 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	7.5% 13/173 • Number of events 13 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	11.7% 20/171 • Number of events 37 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders ALOPECIA	38.7% 67/173 • Number of events 84 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	31.0% 53/171 • Number of events 70 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders DRY SKIN	13.9% 24/173 • Number of events 48 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	10.5% 18/171 • Number of events 23 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders ERYTHEMA	5.8% 10/173 • Number of events 14 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	6.4% 11/171 • Number of events 12 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	20.8% 36/173 • Number of events 55 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	24.6% 42/171 • Number of events 121 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders NIGHT SWEATS	12.1% 21/173 • Number of events 49 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	17.5% 30/171 • Number of events 73 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders PRURITUS	21.4% 37/173 • Number of events 97 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	17.5% 30/171 • Number of events 57 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Skin and subcutaneous tissue disorders RASH	15.6% 27/173 • Number of events 46 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	13.5% 23/171 • Number of events 56 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
Vascular disorders HYPOTENSION	5.2% 9/173 • Number of events 14 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.	8.2% 14/171 • Number of events 20 • Up to One Year An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigators have the right to publish or publicly present the results of the study. Principal Investigators further agree to provide to the Sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication. No publication or manuscript shall contain any trade secret information of the Sponsor or any proprietary or confidential information of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER