Trial Outcomes & Findings for Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects (NCT NCT00709618)

NCT ID: NCT00709618

Last Updated: 2014-07-14

Results Overview

OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions \[TLs\]) or partial response (PR: a \>=30% decrease in the sum of the longest diameter \[LD\] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of \>=1 new lesions)/recurrence.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Results posted on

2014-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg Participants received vinorelbine (20 milligrams per meters squared \[mg/m\^2\]) intravenously (IV) once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Overall Study STARTED	44
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg Participants received vinorelbine (20 milligrams per meters squared \[mg/m\^2\]) intravenously (IV) once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	1
Overall Study Study Closed/Terminated	25

Baseline Characteristics

Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=44 Participants Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Age, Continuous	56.2 Years STANDARD_DEVIATION 12.49 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	32 participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	12 participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Population: Intent-to-Treat (ITT) Population: participants who received \>=1 dose of investigational product. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed \>=4 weeks after response criteria were first met.

OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions \[TLs\]) or partial response (PR: a \>=30% decrease in the sum of the longest diameter \[LD\] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of \>=1 new lesions)/recurrence.

Outcome measures

Outcome measures
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=44 Participants Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Number of Participants With Overall Response (OR), as Assessed by the Investigator	18 participants

SECONDARY outcome

Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Population: ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).

PFS is defined as the time from the start of treatment until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=44 Participants Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Progression-Free Survival (PFS), as Assessed by the Investigator	24.1 weeks Interval 16.9 to 36.7

SECONDARY outcome

Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Population: ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed \>=4 weeks after response criteria were first met.

Duration of response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a \>=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the first documented evidence of CR or PR until the first documented sign of disease progression (a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of \>=1 new lesions) or death due to any cause, if sooner.

Outcome measures

Outcome measures
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=18 Participants Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Duration of Response, as Assessed by the Investigator	32 weeks Interval 18.0 to 42.3

SECONDARY outcome

Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Population: ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed \>=4 weeks after response criteria were first met.

Time to response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a \>=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.

Outcome measures

Outcome measures
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=18 Participants Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Time to Response, as Assessed by the Investigator	7.5 weeks Interval 7.1 to 8.1

SECONDARY outcome

Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Population: ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).

TTP is defined as the time from the start of treatment until the earliest date of disease progression (a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of \>=1 new lesions) or death due to breast cancer, if sooner.

Outcome measures

Outcome measures
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=44 Participants Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Time to Progression (TTP), as Assessed by the Investigator	24.1 weeks Interval 16.9 to 36.7

SECONDARY outcome

Timeframe: From the start of study medication until disease progression, assessed every 4 weeks for up to 2 years

Population: ITT Population

Qualitative and quantitative toxicities associated with the combination of lapatinib and vinorelbine during the study are those adverse events (AEs) that are judged to be related to the study treatment by the investigator. Those AEs occuring in more than 5 participants in the ITT Population are listed here.

Outcome measures

Outcome measures
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=44 Participants Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Diarrhoea	34 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Nausea	24 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Constipation	11 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Vomiting	9 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Abdominal pain	7 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Stomatitis	5 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Neutropenia	29 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Anaemia	9 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Fatigue	20 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Mucosal inflammation	7 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Rash	20 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Neutrophil count decreased	7 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Haemoglobin decreased	6 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine White blood cell count decreased	5 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Neuropathy peripheral	5 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Arthralgia	6 participants
Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine Decreased appetite	8 participants

SECONDARY outcome

Timeframe: From the start of study treatment to the date of death, assessed for up to 3 years

OS is defined as the time from the start of study treatment to the date of death. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Overall survival was not assessed because the study was terminated due to low screening and a low enrollment rate after 3 years. There were no-survival follow-up visits required.

Outcome measures

Outcome data not reported

Adverse Events

Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg

Serious events: 22 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=44 participants at risk Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Blood and lymphatic system disorders Neutropenia	34.1% 15/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Febrile neutropenia	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Gastritis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Oesophagitis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Stomatitis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Dehydration	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperglycaemia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperkalaemia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyponatraemia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Asthenia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Fatigue	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Pyrexia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Perirectal abscess	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Viral upper respiratory tract infection	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Cardiac disorders Left ventricular dysfunction	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood creatinine increased	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Renal and urinary disorders Renal failure acute	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.

Other adverse events

Other adverse events
Measure	Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg n=44 participants at risk Participants received vinorelbine (20 mg/m\^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
Gastrointestinal disorders Diarrhoea	81.8% 36/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Nausea	61.4% 27/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Constipation	34.1% 15/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	31.8% 14/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain	22.7% 10/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Dyspepsia	18.2% 8/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Stomatitis	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 4/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Gastritis	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Mouth ulceration	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain upper	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal discomfort	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Glossitis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Haemorrhoids	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Lip pain	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Lip swelling	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Oedema mouth	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Oesophagitis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Proctalgia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Rectal haemorrhage	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Neutropenia	65.9% 29/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Anaemia	25.0% 11/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Febrile neutropenia	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Leukopenia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Lymphopenia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Thrombocytopenia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Fatigue	52.3% 23/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Mucosal inflammation	15.9% 7/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Pyrexia	15.9% 7/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Pain	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Chest pain	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Inflammation	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Medical device complication	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Non-cardiac chest pain	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Oedema peripheral	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Application site vesicles	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Asthenia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Axillary pain	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Catheter site inflammation	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Chills	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Device infusion issue	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Face oedema	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Ill-defined disorder	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Influenza like illness	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Infusion site erythema	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Infusion site pain	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Local swelling	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
General disorders Malaise	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash	50.0% 22/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	11.4% 5/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Alopecia	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Skin chapped	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Dry skin	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Nail disorder	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Onychoclasis	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus generalised	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Night sweats	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Skin discolouration	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Skin disorder	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Skin exfoliation	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Skin lesion	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Swelling face	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	18.2% 8/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	15.9% 7/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Myalgia	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.1% 4/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in jaw	9.1% 4/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Muscle spasms	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Flank pain	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Neck pain	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Muscular weakness	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Urinary tract infection	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Upper respiratory tract infection	11.4% 5/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Sinusitis	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Vulvovaginal mycotic infection	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Infection	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Oral candidiasis	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Abscess limb	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Acarodermatitis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Breast infection	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Candidiasis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Carbuncle	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Device related infection	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Fungal skin infection	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Herpes zoster	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Nasopharyngitis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Oral herpes	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Perirectal abscess	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Subcutaneous abscess	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Viral upper respiratory tract infection	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypokalaemia	27.3% 12/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	22.7% 10/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Dehydration	18.2% 8/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyponatraemia	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperglycaemia	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypoglycaemia	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperkalaemia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypomagnesaemia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypophosphataemia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Neutrophil count decreased	15.9% 7/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Haemoglobin decreased	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Weight decreased	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations White blood cell count decre	11.4% 5/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood creatinine increased	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Alanine aminotransferase increased	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Aspartate aminotransferase increased	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood alkaline phosphatase increased	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Lymphocyte count decreased	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood bilirubin increased	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood potassium decreased	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood urea increased	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations Breath sounds abnormal	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Investigations White blood cell count increased	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Dizziness	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Headache	11.4% 5/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Neuropathy peripheral	11.4% 5/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Peripheral sensory neuropathy	9.1% 4/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Dysgeusia	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Paraesthesia	6.8% 3/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Ataxia	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Somnolence	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Burning sensation	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Dysarthria	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Migraine	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Restless legs syndrome	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Sedation	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Sinus headache	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	15.9% 7/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.6% 6/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.4% 5/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Sinus congestion	9.1% 4/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Sinus disorder	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Insomnia	25.0% 11/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Depression	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Anxiety	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Confusional state	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Hallucination	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Mood altered	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Restlessness	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Tearfulness	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Hot flush	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Hypertension	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Hypotension	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Jugular vein distension	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Lymphoedema	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Subclavian vein thrombosis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Eye disorders Diplopia	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Eye disorders Lacrimation increased	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Eye disorders Vitreous floaters	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Renal and urinary disorders Dysuria	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Renal and urinary disorders Haematuria	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Renal and urinary disorders Renal failure acute	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Ear and labyrinth disorders Ear pain	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Cholelithiasis	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Hepatic function abnormal	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Immune system disorders Seasonal allergy	4.5% 2/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Cardiac disorders Left ventricular dysfunction	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Endocrine disorders Cushingoid	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Thermal burn	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.
Reproductive system and breast disorders Breast pain	2.3% 1/44 • Serious adverse events (SAEs) and non-serious AEs were collected from the date of the first dose of study treatment until 30 days post last dose (up to 2 years after the start of the study). SAEs and non-serious AE data are reported for the ITT Population, comprised of all participants who received at least one dose of investigational product.

Additional Information

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Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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