Trial Outcomes & Findings for CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer (NCT NCT01033240)

NCT ID: NCT01033240

Last Updated: 2021-04-08

Results Overview

Time to progression was defined as the time from randomization to the date of the first objective documentation of radiographic or symptomatic progression, whichever came first.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 172 participants
• Primary outcome timeframe: Baseline up to approximately 2 years post-dose.
• Results posted on: 2021-04-08

Participant Flow

A total of 172 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at clinic sites in the United States of America (USA), Japan, Taiwan, and South Korea. Ten (10) of the participants were enrolled but did not receive treatment. The data on the 162 treated participants are presented in this report.

Participant milestones

Measure	Sorafenib Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Overall Study STARTED	55	53	55
Overall Study COMPLETED	6	3	2
Overall Study NOT COMPLETED	49	50	53

Reasons for withdrawal

Measure	Sorafenib Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Overall Study Serious Adverse Event (SAE) or Adverse Event	10	8	6
Overall Study Death	2	0	0
Overall Study Withdrew Consent	2	9	2
Overall Study Disease Progression	35	32	41
Overall Study Investigator Discretion	0	0	2
Overall Study Other	0	1	2

Baseline Characteristics

CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer

Baseline characteristics by cohort

Measure	Sorafenib n=55 Participants Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib n=53 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib n=54 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	Total n=162 Participants Total of all reporting groups
Age, Continuous	65.2 years STANDARD_DEVIATION 11.36 • n=5 Participants	60.7 years STANDARD_DEVIATION 12.92 • n=7 Participants	61.1 years STANDARD_DEVIATION 12.47 • n=5 Participants	62.4 years STANDARD_DEVIATION 12.35 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	45 Participants n=7 Participants	45 Participants n=5 Participants	134 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	32 Participants n=7 Participants	37 Participants n=5 Participants	103 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	21 Participants n=7 Participants	17 Participants n=5 Participants	59 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	54 Participants n=5 Participants	52 Participants n=7 Participants	53 Participants n=5 Participants	159 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment South Korea	20 participants n=5 Participants	15 participants n=7 Participants	18 participants n=5 Participants	53 participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Japan	17 participants n=5 Participants	17 participants n=7 Participants	18 participants n=5 Participants	52 participants n=4 Participants
Region of Enrollment Taiwan	17 participants n=5 Participants	20 participants n=7 Participants	17 participants n=5 Participants	54 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 2 years post-dose.

Population: The full analysis set was used to assess TTP.

Time to progression was defined as the time from randomization to the date of the first objective documentation of radiographic or symptomatic progression, whichever came first.

Outcome measures

Measure	Sorafenib n=55 Participants Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib n=53 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib n=54 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Time to Progression (TTP) Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer	2.8 months Interval 1.5 to 6.6	3.0 months Interval 2.6 to 5.5	3.9 months Interval 2.7 to 5.3

SECONDARY outcome

Timeframe: Baseline up to approximately 3 years 2 months post-dose.

Population: The full analysis set was used to assess overall survival.

Overall survival (OS) was defined as the time from randomization to the date of death. The factors in the final model were treatment, Eastern Cooperative Oncology Group (ECOG) performance status, presence of extrahepatic metastasis and/or macrovessel invasion, and region.

Outcome measures

Measure	Sorafenib n=55 Participants Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib n=53 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib n=54 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Overall Survival Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer	8.2 months Interval 4.9 to 13.4	8.2 months Interval 5.7 to 10.4	12.2 months Interval 9.0 to 15.0

SECONDARY outcome

Timeframe: Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 3 years 2 months post-dose.

Population: The full analysis set was used to assess the best overall response and objective response rate.

The best overall response is the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the participant withdraws from the study based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If there is no tumor assessment after the first dose of study drug, the best overall response is classified as Inevaluable. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. Objective response rate was defined as confirmed CR and confirmed PR.

Outcome measures

Measure	Sorafenib n=55 Participants Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib n=53 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib n=54 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Best Overall Response and Objective Response Rate Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Complete Response (CR)	0 Participants	0 Participants	0 Participants
Best Overall Response and Objective Response Rate Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Partial Response (PR)	6 Participants	3 Participants	8 Participants
Best Overall Response and Objective Response Rate Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Objective Response Rate (CR+PR)	6 Participants	3 Participants	8 Participants
Best Overall Response and Objective Response Rate Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Stable Disease (SD)	24 Participants	26 Participants	29 Participants
Best Overall Response and Objective Response Rate Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Progressive Disease (PD)	20 Participants	14 Participants	15 Participants
Best Overall Response and Objective Response Rate Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Inevaluable	5 Participants	10 Participants	2 Participants
Best Overall Response and Objective Response Rate Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Best Overall Response of SD or Better	30 Participants	29 Participants	37 Participants

SECONDARY outcome

Timeframe: Baseline up to 30 days after last dose, up to approximately 3 years 2 months post-dose.

Population: Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.

Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.

Outcome measures

Measure	Sorafenib n=55 Participants Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib n=52 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib n=55 Participants Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Deaths	34 Participants	31 Participants	29 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer TEAEs by worst CTCAE grade: Grade 5	10 Participants	8 Participants	5 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Subjects with ≥1 TEAE	54 Participants	52 Participants	54 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer TEAEs by worst CTCAE grade: CTCAE grade: Grade ≥ 3	43 Participants	44 Participants	46 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer TEAEs related to CS-1008	NA Participants Twelve participants in the sorafenib-only group were mistakenly reported as having experienced TEAEs related to CS-1008. Confirmation from the sites that these participants never received CS-1008.	40 Participants	39 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer TEAEs related to sorafenib	53 Participants	51 Participants	54 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Discontinued CS-1008 due to TEAE	0 Participants	5 Participants	8 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Discontinued sorafenib due to TEAE	18 Participants	7 Participants	9 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer Treatment-Emergent SAEs	25 Participants	26 Participants	20 Participants
Treatment-Emergent Adverse Events Following CS1008 in Combination With Sorafenib Compared to Sorafenib Alone in Participants With Advanced Liver Cancer TEAEs leading to death	11 Participants	8 Participants	6 Participants

Adverse Events

Sorafenib

Serious events: 25 serious events

Other events: 54 other events

Deaths: 34 deaths

CS-1008 6/2 mg/kg + Sorafenib

Serious events: 26 serious events

Other events: 52 other events

Deaths: 31 deaths

CS-1008 6/6 mg/kg + Sorafenib

Serious events: 20 serious events

Other events: 54 other events

Deaths: 29 deaths

Serious adverse events

Measure	Sorafenib n=55 participants at risk Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib n=52 participants at risk Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib n=55 participants at risk Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Blood and lymphatic system disorders Anaemia	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Blood and lymphatic system disorders Pancytopenia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Cardiac disorders Atrial fibrillation	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Cardiac disorders Sinus arrest	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Abdominal distension	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Abdominal pain	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Ascites	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Diarrhoea	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Gastric varices haemorrhage	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Gastritis	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Gingival bleeding	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Haematochezia	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Haemorrhoids	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Oesophageal varices haemorrhage	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Stomatitis	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Varices oesophageal	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Asthenia	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Disease progression	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	11.5% 6/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Fatigue	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Multi-organ failure	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Oedema peripheral	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Pyrexia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Bile duct obstruction	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Cholangitis	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Hepatic failure	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Hepatic function abnormal	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Hepatic infarction	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Hyperbilirubinaemia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Appendicitis	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Biliary sepsis	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Peritonitis bacterial	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Pneumonia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Sepsis	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Urinary tract infection	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Injury, poisoning and procedural complications Fall	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood amylase increased	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations C-reactive protein increased	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Decreased appetitie	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Dehydration	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hypoglycaemia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Myositis	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine carcinoma	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Altered state of consciousness	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Cerebrovascular accident	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Hepatic encephalopathy	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Psychiatric disorders Delirium	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Renal and urinary disorders Azotaemia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Renal and urinary disorders Renal failure acute	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Renal and urinary disorders Urethral stenosis	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Erythema multiforme	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Vascular disorders Haemorrhage	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.

Other adverse events

Measure	Sorafenib n=55 participants at risk Participants with advanced hepatocellular carcinoma who were administered sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/2 mg/kg + Sorafenib n=52 participants at risk Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 2 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.	CS-1008 6/6 mg/kg + Sorafenib n=55 participants at risk Participants with advanced hepatocellular carcinoma who were administered a combination of CS-1008 (6 mg/kg loading dose followed by 6 mg/kg/week maintenance dose) intravenously (IV) once a week + sorafenib (400 mg) orally twice daily over 3-week treatment cycles.
Blood and lymphatic system disorders Anaemia	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Blood and lymphatic system disorders Leukopenia	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Blood and lymphatic system disorders Thrombocytopenia	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Ear and labyrinth disorders Tinnitus	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Abdominal discomfort	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.7% 4/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Abdominal distension	18.2% 10/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	15.4% 8/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Abdominal pain	21.8% 12/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	26.9% 14/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	30.9% 17/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Abdominal pain upper	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	19.2% 10/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	23.6% 13/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Ascites	25.5% 14/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	26.9% 14/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Cheilitis	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Constipation	16.4% 9/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	36.5% 19/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	23.6% 13/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Diarrhoea	49.1% 27/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	44.2% 23/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	65.5% 36/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Dry Mouth	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Dyspepsia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Gingival bleeding	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Mouth ulceration	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Nausea	14.5% 8/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	19.2% 10/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	20.0% 11/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Stomatitis	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Gastrointestinal disorders Vomiting	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	18.2% 10/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Asthenia	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	11.5% 6/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Chills	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Disease progression	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	11.5% 6/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Fatigue	30.9% 17/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	25.0% 13/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	25.5% 14/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Malaise	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	11.5% 6/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Oedema peripheral	20.0% 11/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	26.9% 14/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	18.2% 10/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
General disorders Pyrexia	16.4% 9/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	30.8% 16/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	27.3% 15/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Hepatic function abnormal	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Hepatobiliary disorders Hyperbilirubinaemia	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Nasopharyngitis	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Pneumonia	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Infections and infestations Upper respiratory tract infection	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	15.4% 8/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Alanine aminotransferase increased	25.5% 14/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	26.9% 14/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	27.3% 15/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Aspartate aminotransferase increased	43.6% 24/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	38.5% 20/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	38.2% 21/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood alkaline phosphatase increased	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	16.4% 9/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood amylase increased	14.5% 8/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	23.1% 12/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	20.0% 11/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood bilirubin increased	23.6% 13/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	23.1% 12/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	16.4% 9/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood creatine phosphokinase increased	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood creatinine increased	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood lactate dehydrogenase increased	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Blood urea increased	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Lipase increased	34.5% 19/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	32.7% 17/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	30.9% 17/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Lymphocyte count decreased	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	15.4% 8/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	18.2% 10/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Neutrophil count decreased	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Platelet count decreased	25.5% 14/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	15.4% 8/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	27.3% 15/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Investigations Weight blood cell count decreased	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Decreased appetite	45.5% 25/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	48.1% 25/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	47.3% 26/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Vascular disorders Hypertension	36.4% 20/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	25.0% 13/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	34.5% 19/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hyperkalaemia	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hypoalbuminaemia	23.6% 13/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	23.1% 12/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	21.8% 12/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hypocalcaemia	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hypoglycaemia	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hypokalaemia	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hyponatraemia	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Metabolism and nutrition disorders Hypophosphataemia	25.5% 14/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	32.7% 17/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	30.9% 17/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Back pain	14.5% 8/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	13.5% 7/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	20.0% 11/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Flank pain	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	13.5% 7/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	10.9% 6/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Myalgia	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Neck pain	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.7% 4/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Dizziness	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.7% 4/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Dysgeusia	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Headache	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	15.4% 8/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	16.4% 9/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Hepatic encephalopathy	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Nervous system disorders Neuropathy peripheral	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Psychiatric disorders Insomnia	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	15.4% 8/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	20.0% 11/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Renal and urinary disorders Proteinuria	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Cough	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	13.5% 7/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	20.0% 11/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Dysphonia	25.5% 14/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	26.9% 14/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	25.5% 14/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.7% 4/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Respiratory, thoracic and mediastinal disorders Productive cough	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Acne	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Alopecia	29.1% 16/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	36.5% 19/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	32.7% 18/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Dermatitis acneiform	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Drug eruption	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	9.6% 5/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.8% 2/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Eczema	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	0.00% 0/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Erythema multiforme	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	63.6% 35/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	71.2% 37/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	76.4% 42/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Pruritus	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	13.5% 7/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	16.4% 9/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Pruritus generalized	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Rash	12.7% 7/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.8% 3/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	1.9% 1/52 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline up to 30 days after the last dose, up to approximately 3 years 2 months post-dose. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. An that occurred \>30 days after last dose of study medication was not included as a TEAE unless it was considered related to treatment or the assessment of relatedness was missing.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

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