Trial Outcomes & Findings for Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301) (NCT NCT04248829)

NCT ID: NCT04248829

Last Updated: 2024-12-03

Results Overview

PFS was defined as the time from randomization until the date of objective progression or death(by any cause whichever comes first based on investigator assessment using RECIST v1.1 and was used to assess the efficacy of lazertinib compared to the gefitinib).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 393 participants
• Primary outcome timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.
• Results posted on: 2024-12-03

Participant Flow

A total of 393 participants were randomized to treatment at 96 study sites in 13 countries.

During the 28 day screening period, participants were enrolled based on the presence in their tumour of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations. At the time of enrolment, all participants were required to provide biopsy tissue for central testing of the Exon 19 deletion (Ex19del) and L858R mutations.

Participant milestones

Measure	Lazertinib 240 mg Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg Randomized participants received Gefitinib 250 mg orally once daily (QD)
Overall Study STARTED	196	197
Overall Study COMPLETED	108	47
Overall Study NOT COMPLETED	88	150

Reasons for withdrawal

Measure	Lazertinib 240 mg Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg Randomized participants received Gefitinib 250 mg orally once daily (QD)
Overall Study Disease progression	44	109
Overall Study Adverse Event	19	18
Overall Study Withdrawal by Subject	11	2
Overall Study Lost to Follow-up	0	1
Overall Study Death	12	14
Overall Study Physician Decision	2	4
Overall Study Any reason not specifically recorded	0	2

Baseline Characteristics

Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

Baseline characteristics by cohort

Measure	Lazertinib 240 mg n=196 Participants Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 Participants Randomized participants received Gefitinib 250 mg orally once daily (QD)	Total n=393 Participants Total of all reporting groups
Age, Customized	67 years n=5 Participants	64 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	132 Participants n=5 Participants	119 Participants n=7 Participants	251 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	78 Participants n=7 Participants	142 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	130 Participants n=5 Participants	130 Participants n=7 Participants	260 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-Asian	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Smoking history Never	135 Participants n=5 Participants	149 Participants n=7 Participants	284 Participants n=5 Participants
Smoking history Former	50 Participants n=5 Participants	42 Participants n=7 Participants	92 Participants n=5 Participants
Smoking history Current	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

Population: The full analysis set (FAS), FAS included all randomized participants.

PFS was defined as the time from randomization until the date of objective progression or death(by any cause whichever comes first based on investigator assessment using RECIST v1.1 and was used to assess the efficacy of lazertinib compared to the gefitinib).

Outcome measures

Measure	Lazertinib 240 mg n=196 Participants Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 Participants Randomized participants received Gefitinib 250 mg orally once daily (QD)
Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment	20.6 Months Interval 17.8 to 26.1	9.7 Months Interval 9.2 to 11.3

SECONDARY outcome

Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

Population: The full analysis set (FAS), FAS included all randomized participants.

ORR was defined as the percentage of participants with measurable disease with at least on visit response of complete response(CR) or Partial response(PR) and it was used to further assess the efficacy of lazertinib compared with gefitinib.

Outcome measures

Measure	Lazertinib 240 mg n=196 Participants Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 Participants Randomized participants received Gefitinib 250 mg orally once daily (QD)
Objective Response Rate (ORR) According to RECIST v1.1 by Investigator Assessments	76.0 Percentage of participants Interval 69.4 to 81.8	76.1 Percentage of participants Interval 69.6 to 81.9

SECONDARY outcome

Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

Population: The full analysis set (FAS), FAS included all randomized participants.

DoR was defined as the time from the date of first documented response(CR or PR) until the date of documented progression or death, whichever comes first and was used to further assess the efficacy of lazertinib compared with gefitinib.

Outcome measures

Measure	Lazertinib 240 mg n=196 Participants Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 Participants Randomized participants received Gefitinib 250 mg orally once daily (QD)
Duration of Response (DoR) According to RECIST v1.1 by Investigator Assessments	19.4 Months Interval 16.6 to 24.9	8.3 Months Interval 6.9 to 10.9

SECONDARY outcome

Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

Population: The full analysis set (FAS), FAS included all randomized participants.

DCR was defined as the percentage of participants who have a best overall response of CR or PR or SD(SD at >= 6weeks prior to any PD event) and was used to further assess the efficacy of lazertinib compared with gefitinib.

Outcome measures

Measure	Lazertinib 240 mg n=196 Participants Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 Participants Randomized participants received Gefitinib 250 mg orally once daily (QD)
Disease Control Rate (DCR) According to RECIST v1.1 by Investigator Assessments	93.9 Percentage of participants Interval 89.5 to 96.8	93.9 Percentage of participants Interval 89.6 to 96.8

SECONDARY outcome

Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression.

The depth of response was defined as the best percent change in the sum of diameters of target lesions in the absense of new lesions or progression of non-target lesions compared to the baseline and was used to further assess the efficacy of lazertinib compared with gefitinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression.

Time to Response was defined as the time from the date of randomization until the date of first documented response and was used to further assess the efficacy of lazertinib compared with gefitinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the randomization to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks. (Up to 29 months per participant.)

Population: The full analysis set (FAS), FAS included all randomized participants.

OS was defined as the time from the date of randomization until the date of death due to any cause and was used to further assess the efficacy of lazertinib compared with gefitinib.

Outcome measures

Measure	Lazertinib 240 mg n=196 Participants Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 Participants Randomized participants received Gefitinib 250 mg orally once daily (QD)
Overall Survival (OS) Death	49 Participants	64 Participants
Overall Survival (OS) Alive/Censored	147 Participants	133 Participants

SECONDARY outcome

Timeframe: Blood samples collected from each participant at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1 Cycle 1, Day 1 Cycle 2, Day 1 Cycle 5, Day 1 Cycle 9, and Day 1 Cycle 13.

To characterize the pharmacokinetics (PK) of lazertinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: A cerebrospinal fluid (CSF) sample once collected from participants with brain metastases, at Cycle 5 Day 1 or afterward.

To characterize the pharmacokinetics (PK) of lazertinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later).

The EORTC QLQ-C30 consists of 30 items and measures cancer participants' functioning (health related quality of life (HRQoL)) and symptoms for all cancer types. Questions can be grouped into 5 multi item functional scales (physical, role, emotional, cognitive, and social); 3 multi item symptom scales (fatigue, pain, nausea/vomiting); a 2 item global HRQoL scale; 5 single items assessing additional symptoms commonly reported by cancer participants (dyspnea, loss of appetite, insomnia, constipation, diarrhea) and 1 item on the financial impact of the disease.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

• a high score for a functional scale represents a high / healthy level of functioning
• a high score for the global health status / QoL represents a high QoL
• but a high score for a symptom scale / item represents a high level of symptomatology / problems

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later).

The EORTC QLQ-LC13 includes questions assessing cough, hemoptysis, dyspnea, site specific pain (symptoms), sore mouth, dysphagia, peripheral neuropathy, and alopecia (treatment related side effects), and pain medication.

The items on both measures were scaled and scored using the recommended EORTC procedures. Raw scores were transformed to a linear scale ranging from 0 to 100, with a higher score representing a higher level of functioning or higher level of symptoms. Provided at least half of the items in the scale were completed, the scale score was calculated using only those items for which values existed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later).

The EQ-5D comprises the following two questionnaires:

• The EQ-5D comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension comprises five levels (no problems, slight problems, moderate problem, severe problem, unable/extreme problems).
• The EQ VAS records the participants self-rated health status on a vertical graduated (0-100) visual analogue scale. The patient's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.

Outcome measures

Outcome data not reported

Adverse Events

Lazertinib 240 mg

Serious events: 51 serious events

Other events: 189 other events

Deaths: 49 deaths

Gefitnib 250 mg

Serious events: 51 serious events

Other events: 188 other events

Deaths: 64 deaths

Serious adverse events

Measure	Lazertinib 240 mg n=196 participants at risk Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 participants at risk Randomized participants received Gefitinib 250 mg orally once daily (QD)
Infections and infestations COVID-19	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.5% 3/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.1% 8/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.5% 3/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Pneumonia	4.1% 8/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.5% 3/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Actinomycosis	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Bronchiolitis	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Empyema	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Gangrene	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Pneumonia aspiration	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Sepsis	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Septic shock	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Urosepsis	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.5% 3/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Bronchitis	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Infectious pleural effusion	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Appendicitis	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations COVID-19 pneumonia	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Cellulitis	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Gastroenteritis	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Suspected COVID-19	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Urinary tract infection	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Wound infection staphylococcal	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Diarrhoea	1.5% 3/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Gastritis	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Vomiting	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Stomatitis	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Lower limb fracture	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Fall	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Fibula fracture	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Spinal compression fracture	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Tibia fracture	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Wrist fracture	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Death	1.5% 3/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.5% 3/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Oedema peripheral	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Asthenia	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Systemic inflammatory response syndrome	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Fatigue	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Pyrexia	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Psychiatric disorders Anxiety	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal papilloma	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Metabolism and nutrition disorders Hyponatraemia	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Metabolism and nutrition disorders Decreased appetite	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Metabolism and nutrition disorders Hypoglycaemia	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Nervous system disorders Cerebrovascular accident	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Nervous system disorders Transient ischaemic attack	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Nervous system disorders Leukoencephalopathy	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Renal and urinary disorders Acute kidney injury	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	2.0% 4/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Renal and urinary disorders Azotaemia	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Cardiac disorders Myocardial infarction	1.0% 2/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Cardiac disorders Cardiac failure acute	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Cardiac disorders Cardiac arrest	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Cardiac disorders Pericardial effusion	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Psychiatric disorders Completed suicide	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Psychiatric disorders Depression	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Musculoskeletal and connective tissue disorders Pathological fracture	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Blood and lymphatic system disorders Anaemia	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Congenital, familial and genetic disorders Thyroglossal cyst	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Hepatobiliary disorders Cholecystitis	0.51% 1/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.00% 0/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Vascular disorders Circulatory collapse	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Vascular disorders Embolism	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Vascular disorders Hypertension	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Vascular disorders Orthostatic hypotension	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Vascular disorders Venous thrombosis limb	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Alanine aminotransferase increased	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Aspartate aminotransferase increased	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.0% 2/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Blood creatinine increased	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Hepatic enzyme increased	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Skin and subcutaneous tissue disorders Rash	0.00% 0/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	0.51% 1/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.

Other adverse events

Measure	Lazertinib 240 mg n=196 participants at risk Randomized participants received Lazertinib 240 mg orally once daily (QD)	Gefitnib 250 mg n=197 participants at risk Randomized participants received Gefitinib 250 mg orally once daily (QD)
Skin and subcutaneous tissue disorders Alopecia	7.1% 14/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	9.6% 19/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Skin and subcutaneous tissue disorders Rash	36.2% 71/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	36.5% 72/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Skin and subcutaneous tissue disorders Pruritus	26.5% 52/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	18.3% 36/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Skin and subcutaneous tissue disorders Paronychia	17.9% 35/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	17.3% 34/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Skin and subcutaneous tissue disorders Dry skin	14.8% 29/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	11.7% 23/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Skin and subcutaneous tissue disorders Dermatitis acneiform	10.7% 21/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	13.7% 27/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Nervous system disorders Paraesthesia	39.3% 77/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	6.6% 13/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Nervous system disorders Headache	9.2% 18/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	5.1% 10/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Nervous system disorders Dizziness	5.6% 11/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	5.1% 10/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Diarrhoea	26.0% 51/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	39.1% 77/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Stomatitis	15.8% 31/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	8.1% 16/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Nausea	15.3% 30/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	9.1% 18/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Constipation	14.3% 28/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	10.2% 20/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Vomiting	5.1% 10/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	7.1% 14/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Alanine aminotransferase increased	15.3% 30/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	29.9% 59/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Aspartate aminotransferase increased	11.2% 22/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	26.4% 52/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Blood alkaline phosphatase increased	6.1% 12/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	6.1% 12/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Weight decreased	4.6% 9/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	7.1% 14/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Investigations Gamma-glutamyltransferase increased	4.1% 8/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	6.6% 13/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations COVID-19	8.2% 16/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	7.1% 14/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Urinary tract infection	5.1% 10/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	7.1% 14/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Infections and infestations Pneumonia	5.1% 10/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	5.6% 11/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Musculoskeletal and connective tissue disorders Muscle spasms	13.3% 26/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	3.6% 7/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 17/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	8.6% 17/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Musculoskeletal and connective tissue disorders Back pain	7.7% 15/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	6.1% 12/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Cough	8.7% 17/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	7.1% 14/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.2% 16/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	7.1% 14/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Metabolism and nutrition disorders Decreased appetite	16.8% 33/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	15.7% 31/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Metabolism and nutrition disorders Hyperkalaemia	6.1% 12/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	4.1% 8/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Fatigue	8.2% 16/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	4.1% 8/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Asthenia	6.1% 12/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	4.1% 8/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Blood and lymphatic system disorders Anaemia	18.4% 36/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	11.7% 23/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Psychiatric disorders Insomnia	5.6% 11/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	5.6% 11/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Blood and lymphatic system disorders thrombocytopenia	6.6% 13/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	3.6% 7/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Vascular disorders Hypertension	4.1% 8/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	5.1% 10/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	6.6% 13/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	3.0% 6/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Gastrointestinal disorders Dyspepsia	5.1% 10/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	4.6% 9/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 11/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	2.5% 5/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Metabolism and nutrition disorders Hyponatraemia	5.1% 10/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	1.5% 3/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
General disorders Oedema peripheral	6.1% 12/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	2.5% 5/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	2.0% 4/196 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.	6.6% 13/197 • All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.) An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.

Additional Information

Dongmin Kim

Yuhan Corporation

Phone: +82-2-828-0523

Email: clinicaltrials@yuhan.co.kr

Results disclosure agreements

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