Trial Outcomes & Findings for MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC (NCT NCT04633564)

Last Updated: 2022-03-16

Results Overview

The primary efficacy endpoint Overall Response Rate (ORR) will be based on best tumor responses as assessed by an independent review at any time point during the first 18 weeks, and assessed according to RECIST 1.1. The primary efficacy analysis is based on the ratio of the MYL-1402O ORR to the Avastin ORR at Week 18 based on the Intent to Treat ( ITT) set of patients.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

671 participants

Primary outcome timeframe

18 weeks after first dosing per patient

Results posted on

2022-03-16

Participant Flow

671 subjects enrolled at 89 sites across Eastern Europe, Russia, Asia Pacific, South East Asia. Date of first patient randomized: 21 Jan 2017 Date of last patient randomized: 31 Jan 2019

A total of 1016 patients were screened; 345 patients were screen failures. Most common reasons for screen failures were; 57=met exclusion criteria tumor location in contact with major vessels, 46= withdrew consent; 37= patients who have brain metastasis which was treated and stable at the time of signing ICF and 36= patients did not have at least 1 measurable lesion as defined by RECIST 1.1.

Participant milestones

Participant milestones
Measure	MYL-1402O Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV	Avastin Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Period 1 STARTED	335	329
Period 1 COMPLETED	227	220
Period 1 NOT COMPLETED	108	109
Period 2 STARTED	200	199
Period 2 COMPLETED	107	102
Period 2 NOT COMPLETED	93	97

Reasons for withdrawal

Reasons for withdrawal
Measure	MYL-1402O Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV	Avastin Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Period 1 Adverse Event	28	19
Period 1 Death	8	7
Period 1 Lost to Follow-up	3	5
Period 1 Physician Decision	4	12
Period 1 Protocol Violation	0	1
Period 1 Withdrawal by Subject	10	8
Period 1 Progressive disease	47	51
Period 1 Terminated by Sponsor	8	6
Period 2 Adverse Event	3	4
Period 2 Death	0	2
Period 2 Lost to Follow-up	0	1
Period 2 Physician Decision	2	4
Period 2 Withdrawal by Subject	5	1
Period 2 Progressive Disease	74	82
Period 2 Terminated by Sponsor	9	3

Baseline Characteristics

7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MYL-1402O n=337 Participants Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV	Avastin n=334 Participants Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV	Total n=671 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.	0 Participants n=7 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.	0 Participants n=5 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.
Age, Categorical Between 18 and 65 years	237 Participants n=5 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.	236 Participants n=7 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.	473 Participants n=5 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.
Age, Categorical >=65 years	100 Participants n=5 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.	98 Participants n=7 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.	198 Participants n=5 Participants • 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed.
Age, Continuous	59.3 Years STANDARD_DEVIATION 9.60 • n=5 Participants	59.2 Years STANDARD_DEVIATION 9.73 • n=7 Participants	59.3 Years STANDARD_DEVIATION 9.66 • n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	123 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Male	213 Participants n=5 Participants	211 Participants n=7 Participants	424 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	226 Participants n=5 Participants	232 Participants n=7 Participants	458 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	111 Participants n=5 Participants	102 Participants n=7 Participants	213 Participants n=5 Participants
Region of Enrollment Romania	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Hungary	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Philippines	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Ukraine	86 participants n=5 Participants	74 participants n=7 Participants	160 participants n=5 Participants
Region of Enrollment Belarus	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment India	99 participants n=5 Participants	92 participants n=7 Participants	191 participants n=5 Participants
Region of Enrollment Russia	65 participants n=5 Participants	75 participants n=7 Participants	140 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Vietnam	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Turkey	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Taiwan	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Poland	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Georgia	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Bulgaria	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Bosnia and Herzegovina	8 participants n=5 Participants	11 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Croatia	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 weeks after first dosing per patient

Population: The primary efficacy analysis was conducted in the Intent To Treat population (ITT)

Outcome measures

Outcome measures
Measure	MYL-1402O n=337 Participants Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV	Avastin n=334 Participants Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin Non-Responders	197 Participants	190 Participants
Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin Responders	140 Participants	144 Participants

Adverse Events

MYL-1402O

Serious events: 59 serious events

Other events: 311 other events

Deaths: 101 deaths

Avastin

Serious events: 55 serious events

Other events: 304 other events

Deaths: 82 deaths

Serious adverse events

Other adverse events

Additional Information

Keri Vaughan, Senior Director

Mylan GmbH

Phone: +215.280.2846

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	MYL-1402O n=335 participants at risk Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV	Avastin n=329 participants at risk Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.2% 4/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	1.2% 4/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	1.2% 4/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.91% 3/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 5/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.61% 2/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.60% 2/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.60% 2/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Aspiration	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary Thrombosis	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Febrile Neutropenia	2.1% 7/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	1.5% 5/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Thrombocytopenia	1.2% 4/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	1.8% 6/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Anaemia	1.5% 5/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Neutropenia	1.2% 4/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.61% 2/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Leukopenia	0.60% 2/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Sepsis	0.90% 3/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.61% 2/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Pneumonia	0.90% 3/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Gastroenteritis	0.90% 3/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Infectious Pleural Effusion	0.60% 2/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Peritonitis	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.61% 2/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Cellulitis	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Ear Infection	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Eye Infection Fungal	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Gastroenteritis Salmonella	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Gastrointestinal Infection	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Hepatitis C	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Herpes Zoster	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Lung Infection	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Rectal Abscess	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Respiratory Tract Infection	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Infections and infestations Septic Shock	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Diarrhoea	0.30% 1/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.91% 3/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Vomiting	0.60% 2/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.00% 0/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Duodenal Ulcer	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.00% 0/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	0.30% 1/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.

Other adverse events
Measure	MYL-1402O n=335 participants at risk Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV	Avastin n=329 participants at risk Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Blood and lymphatic system disorders Anaemia	33.1% 111/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	34.0% 112/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Thrombocytopenia	31.0% 104/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	24.3% 80/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Neutropenia	20.3% 68/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	23.1% 76/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Blood and lymphatic system disorders Leukopenia	11.3% 38/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	12.5% 41/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Skin and subcutaneous tissue disorders Alopecia	44.2% 148/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	51.1% 168/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Nervous system disorders Peripheral Sensory Neuropathy	22.1% 74/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	20.1% 66/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Nervous system disorders Headache	7.8% 26/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	5.2% 17/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Nervous system disorders Hypoaesthesia	4.5% 15/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	6.1% 20/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Nausea	16.7% 56/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	14.9% 49/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Vomiting	16.1% 54/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	11.6% 38/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Diarrhoea	13.7% 46/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	9.1% 30/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Gastrointestinal disorders Stomatitis	6.6% 22/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	2.4% 8/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
General disorders Asthenia	15.8% 53/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	10.0% 33/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
General disorders Pyrexia	9.3% 31/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	6.4% 21/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
General disorders Fatigue	7.8% 26/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	8.2% 27/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Investigations Alanine Aminotranferase Increased	7.5% 25/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	8.8% 29/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Investigations Aspartate Aminotransferase Increased	6.6% 22/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	5.8% 19/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Investigations Weight decreased	6.6% 22/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	2.1% 7/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.3% 21/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	4.9% 16/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 15/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	7.0% 23/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.8% 6/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	5.2% 17/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 16/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	5.5% 18/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Metabolism and nutrition disorders Decreased Appetite	12.8% 43/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	9.7% 32/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Vascular disorders Hypertension	5.7% 19/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	4.9% 16/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
Renal and urinary disorders Proteinuria	3.3% 11/335 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.	5.2% 17/329 • Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death. The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.