A Study to Test Different Doses of BI 836880 Combined Wit... | NCT03468426

ID	Type	Description	Link
2017-001378-41	EudraCT Number

Label	Type	Description	Intervention Names
Part 1 - BI 836880 360 mg	Experimental	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	Drug: BI 836880 Drug: Ezabenlimab
Part 1 - BI 836880 500 mg	Experimental	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	Drug: BI 836880 Drug: Ezabenlimab
Part 1 - BI 836880 720 mg	Experimental	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	Drug: BI 836880 Drug: Ezabenlimab
Part 2 - Cohort A, 2nd line NSCLC	Experimental	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Name	Type	Description	Arm Group Labels	Other Names
BI 836880	Drug	BI 836880 as an intravenous infusion on day 1 of each 3-week cycle.	Part 1 - BI 836880 360 mg Part 1 - BI 836880 500 mg Part 1 - BI 836880 720 mg

Measure	Description	Time Frame
Part 1 - Number of Patients With Dose Limiting Toxicity (DLT) Within the First Cycle of Treatment	Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment.	The first treatment cycle, up to 21 days.
Part 2 - Objective Response (OR)	Objective Response (OR) defined as best overall response (Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)) of complete response (CR) or partial response (PR) from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent. In case of recurrent glioblastoma (GBM), assessment will be based on RANO (Response Assessment in Neuro-Oncology) criteria.	Up to 778 days.

Measure	Description	Time Frame
Part 1 - Adverse Events (AEs)	The number of patients with any adverse events (AEs).	Up to 1263 days.
Part 1 - Drug Related AEs	The number of patients with any drug related adverse events (AEs).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Part 1:

Of full age (according to local legislation, usually ≥ 18 years) at screening.
Pathologically confirmed locally advanced or metastatic non-squamous NSCLC with PDL-1 expression available and >1% by IHC (as defined by the Pembrolizumab companion diagnostic test, determined by appropriate local pathology lab.
No previous treatment with check-point inhibitor. Or patients with checkpoint inhibitor based treatment as last therapy before entering the trial.
Documented disease progression or relapse (based on investigator's assessment) during or after completion of at least 2 cycles of platinum-based chemotherapy as first line treatment of Stage IIIB/IV non- squamous NSCLC or for checkpoint inhibitor experienced patients during or after completion of at least 2 cycles of platinum-based chemotherapy and a checkpoint inhibitor treatment (monotherapy or in combination with chemotherapy). This includes patients relapsing within 6 months of completing (neo)adjuvant/curative-intent chemotherapy/CPI or chemoradiotherapy
At least one target lesion (outside the brain) that can be accurately measured per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 .
Lesion with a diameter ≥ 2cm assessed by radiologist as suitable for DCE-MRI evaluation (Mandatory in Part 1, optional in Part 2)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Life expectancy ≥ 3 months after start of the treatment in the opinion of the investigator
Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE grade 1, except for alopecia (any grade), sensory peripheral neuropathy , must be ≤ CTCAE grade 2 or considered not clinically significant.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Availability and willingness to provide a fresh tumour tissue sample obtained at baseline, and after 2 cycles of treatment
Adequate organ function defined as all of the following (all screening labs should be performed at local lab within 10 days prior to treatment initiation)
Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, starting with the screening visit and through 6 months after the last dose of BI 836880 and BI 754091 treatment, respectively. A list of contraception methods meeting these criteria is provided in the patient information Note: Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to taking study medication during the screening period. At the following visits according to the flowchart a urine and/or serum pregnancy test is required. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.

Part 2:

Of full age (according to local legislation, usually ≥ 18 years) at screening
At least one measurable target lesion outside the brain (excluding the glioblastoma patients where brain lesions are allowed), that can be accurately measured per RECIST version 1.1 or Response Assessment in Neuro-Oncology (RANO)
ECOG performance status ≤ 1 (For glioblastoma cohort Karnofsky status is applicable)
Adequate organ function as all of the following (all screening labs should be performed at local lab within approximately 72 hours prior to treatment initiation)
Availability and willingness to provide a fresh tumor tissue sample obtained after relapse or progression on or after prior therapy. For Part 2, In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen obtained up to 6 months prior to cycle 1, visit 1 (C1V1) may be submitted in case no systemic antineoplastic therapy has been administered between the biopsy and C1V1 (except for cohort D). For cohorts E, F and G, a fresh on-treatment biopsy is mandatory at C3D1, if possible from the same lesion as the pre-treatment biopsy.
Life expectancy ≥ 3 months after start of the treatment in the opinion of the investigator
Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE grade 1, except for alopecia (any grade), sensory peripheral neuropathy , must be ≤ CTCAE grade 2 or considered not clinically significant.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Male or female patients. Women of childbearing potential (WOCBP)2 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, for the entire duration of the trial treatment intake and for 6 months after the end of the trial treatment. A list of contraception methods meeting these criteria is provided in the patient information.

Note: Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours during the screening period. At the following visits according to the flowchart, a urine and/or serum pregnancy test is required. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.- Further inclusion criteria apply

Exclusion criteria:

Part 1:

Known hypersensitivity to the trial drugs or their excipients or risk of allergic of anaphylactic reaction to drug product according to Investigator judgement (e.g. patient with history of anaphylactic reaction or autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of </= 10 mg/day prednisone).
Known immunodeficiency virus infection or an active hepatitis B or C virus infection.
History of severe hypersensitivity reactions to other mAbs.
Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of trial medication.
Current or prior treatment with any systemic anti-cancer therapy either within 28 days or a minimum of 5 half-lives, whichever is shorter before start of treatment.
Serious concomitant disease, especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the endpoints of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastrointestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
Major injuries and/or surgery or bone fracture within 4 weeks of start of treatment, or planned surgical procedures during the trial period.
Patients with personal or family history of QT prolongation and/or long QT syndrome, or prolonged QTcF at baseline (> 480 ms).
Significant cardiovascular/cerebrovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > NYHA II).

Uncontrolled hypertension defined as: Blood pressure in rested and relaxed condition >= 140 mmHg, systolic or >= 90 mmHg diastolic (with or without medication), measured according to Appendix 10.2.

LVEF < 50%
History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
Known inherited predisposition to bleeding or to thrombosis in the opinion of the investigator.
Patient with brain metastases that are symptomatic and/or require therapy.
Patients who require full-dose anticoagulation (according to local guidelines). No Vitamin K antagonist and other anticoagulation allowed; LMWH allowed only for prevention not for curative treatment.
History of pneumonitis within the last 5 years
Patients who are under judicial protection and patients who are legally institutionalized.
Patients unable or unwilling to comply with protocol
Previous enrolment in this trial (Part 1 or Part 2).
Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
Women who are pregnant, nursing, or who plan to become pregnant in the trial

Part 2:

Known hypersensitivity to the trial drugs or their excipients or risk of allergic of anaphylactic reaction to drug product according to Investigator judgement (e.g. patient with history of anaphylactic reaction or autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of </= 10 mg/day prednisone).
Not more than one CPI based treatment regimen prior to entering study (e.g. anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody). In case of CPIs combination, they need to be approved by the local regulatory agencies; for e.g., Melanoma cohort (Cohort E).
Known HIV infection
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (exception for patients in HCC cohorts; Cohorts F& G).
History of severe hypersensitivity reactions to other mAbs.
Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of trial medication except for control of cerebral edema in case of recurrent glioblastoma (cohort D).
Current or prior treatment with any systemic anti-cancer therapy (including radiotherapy) either within 28 days or a minimum of 5 half-lives, whichever is shorter before start of treatment
Serious concomitant disease, especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the endpoints of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastrointestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
Major injuries and/or surgery or bone fracture within 4 weeks of start of treatment, or planned surgical procedures during the trial period.
Patients with personal or family history of QT prolongation and/or long QT syndrome, or prolonged QTcF at baseline (> 480 ms).
Significant cardiovascular/cerebrovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > NYHA II).

Uncontrolled hypertension defined as: Blood pressure in rested and relaxed condition >= 140 mmHg, systolic or >= 90 mmHg diastolic (with or without medication), measured according to Appendix 10.2.

LVEF < 50%
History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
Known inherited predisposition to bleeding or to thrombosis in the opinion of the investigator.
Patient with brain metastases that are symptomatic and/or require therapy.
Patients who require full-dose anticoagulation (according to local guidelines).
No Vitamin K antagonist and other anticoagulation allowed; LMWH allowed only for prevention not for curative treatment.
History of pneumonitis (non-infectious) within the last 5 years
Patients who are under judicial protection and patients who are legally institutionalized.
Patients unable or unwilling to comply with protocol
Previous enrolment in this trial.
Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
Women who are pregnant, nursing, or who plan to become pregnant in the trial
UncontrolledSymptomatic pleural effusion, pericardial effusion, or ascites
Prior treatment with any antiangiogenic treatment (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL-184, sunitinib, etc) except for sorafenib and lenvatinib in 2nd line HCC cohort (Cohort F)
Has received a live vaccine within 30 days prior to the first dose of study drug
Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening
Further exclusion criteria apply

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35249	United States
Beverly Hills Cancer Center

Label	URL
Related Info	View source

ID	Title	Description
FG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 18, 2023	Sep 8, 2025

Arm/Group Information

ID	Title	Description
BG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG002	Part 1 - BI 836880 720 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG003	Part 2 - Cohort A, 2nd Line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG004	Part 2 - Cohort B, 3rd Line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG005	Part 2 - Cohort C, SCLC	Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG006	Part 2 - Cohort D, Glioblastoma	Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG007	Part 2 - Cohort E, Melanoma	Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG008	Part 2 - Cohort F, 2nd Line Hepatocellular Carcinoma	Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG009	Part 2 - Cohort G, 1st Line Hepatocellular Carcinoma (HCC)	Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG010	Part 2 - Cohort H, 2nd Line HCC - Atezolizumab in Combination With Bevacizumab Failures	Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
BG011	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Part 1 - Adverse Events (AEs)

The number of patients with any adverse events (AEs).

All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 1263 days.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG002	Part 1 - BI 836880 720 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG003	Part 1 - total	All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Units	Counts
Participants	OG0003 OG0013 OG0028 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0013 OG0028 OG003

Secondary

Part 1 - Drug Related AEs

The number of patients with any drug related adverse events (AEs).

All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 1263 days.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG002	Part 1 - BI 836880 720 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation

The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.

All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 1263 days.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG002	Part 1 - BI 836880 720 mg

Secondary

Part 2 - Adverse Events (AEs)

The number of patients with any adverse events (AEs).

All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 778 days.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 2 - Drug Related AEs

The number of patients with any drug related adverse events (AEs).

All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 778 days.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation

The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.

All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 778 days.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 2 - Disease Control (DC)

Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) (Response Assessment in Neuro-Oncology (RANO for GBM & RECIST1.1 for all other cohorts).

All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 778 days.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 2 - Duration of Objective Response (DoR)

Duration of objective response (DoR), defined as the time from first documented CR or PR (RANO for GBM & RECIST1.1 for all other cohorts) until the earliest of disease progression or death among patients with OR.

All patients with an objective response enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Median

Full Range

weeks

Up to 84.4 weeks.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 2 - Progression-free Survival (PFS)

Progression-free survival (PFS) (RANO for GBM & RECIST1.1 for all other cohorts), defined as the time from first treatment infusion until disease progression or death from any cause, whichever occurs earlier. Tumour shrinkage (in millimeters), defined as the difference between the minimum post-baseline sum of diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions in case of RECIST. In GBM, using RANO criteria, tumor shrinkage will be calculated based on the difference between the post-baseline and baseline measurements of the sum of product of the largest bi-dimensional measurements for all target lesions.

All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Median

Inter-Quartile Range

weeks

Up to 778 days.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001

Secondary

Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle

Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.

PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the Fourth Infusion Cycle

Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the fourth infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle

Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the Fourth Infusion Cycle

Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the fourth infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle

Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle

Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 2 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle

Part 2 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.

PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC

Secondary

Part 2 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle

Part 2 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC

Secondary

Part 2 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle

Part 2 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.

PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC

Secondary

Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle

Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the Fourth Infusion Cycle

Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the fourth infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle

Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the Fourth Infusion Cycle

Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the fourth infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle

Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle

Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Secondary

Part 2 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle

Part 2 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC

Secondary

Part 2 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle

Part 2 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC

Secondary

Part 2 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle

Part 2 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*microgram/milliliter

5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001

Primary

Part 1 - Number of Patients With Dose Limiting Toxicity (DLT) Within the First Cycle of Treatment

Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment.

Maximum tolerated dose (MTD) set: This patient set includes all patients enrolled in dose escalation and confirmation of MTD cohort of the trial (Part 1) who were documented to have received at least one dose of ezabenlimab or BI 836880 and were evaluable for the MTD determination.

Posted

Count of Participants

Participants

The first treatment cycle, up to 21 days.

ID	Title	Description
OG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Primary

Part 2 - Objective Response (OR)

Objective Response (OR) defined as best overall response (Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)) of complete response (CR) or partial response (PR) from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent. In case of recurrent glioblastoma (GBM), assessment will be based on RANO (Response Assessment in Neuro-Oncology) criteria.

All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.

Posted

Count of Participants

Participants

Up to 778 days.

ID	Title	Description
OG000	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
OG001	Part 2 - Cohort B, 3rd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1 - BI 836880 360 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	0	3	2	3	3	3
EG001	Part 1 - BI 836880 500 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	1	3	3	3	3	3
EG002	Part 1 - BI 836880 720 mg	Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	1	8	6	8	8	8
EG003	Part 2 - Cohort A, 2nd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	4	42	24	42	36	42
EG004	Part 2 - Cohort B, 3rd line NSCLC	Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	2	40	21	40	35	40
EG005	Part 2 - Cohort C, SCLC	Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	5	31	14	31	23	31
EG006	Part 2 - Cohort D, glioblastoma	Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	1	31	10	31	28	31
EG007	Part 2 - Cohort E, Melanoma	Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	2	32	11	32	30	32
EG008	Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma	Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	4	30	16	30	28	30
EG009	Part 2 - Cohort G, 1st line Hepatocellular Carcinoma	Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	5	31	17	31	27	31
EG010	Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures	Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.	0	1	0	1	1	1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac tamponade	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG0031 affected42 at risk EG0040 affected40 at risk EG0050 affected31 at risk EG0060 affected31 at risk EG0070 affected32 at risk EG0080 affected30 at risk EG0090 affected31 at risk EG0100 affected1 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Death	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abscess limb	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Device related infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Stoma site cellulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sciatica	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Device breakage	Product issues	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastroduodenal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Chills	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Disease progression	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
General physical health deterioration	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hyperthermia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ill-defined disorder	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Perforated ulcer	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Encephalitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Skin infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Spontaneous bacterial peritonitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tracheal haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Coma scale abnormal	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Transaminases increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Aphasia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Paraneoplastic myelopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Seizure	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Thrombosis in device	Product issues	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Delirium	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Autoimmune nephritis	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pyelocaliectasis	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Embolism venous	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Peripheral venous disease	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG0035 affected42 at risk EG0045 affected40 at risk EG0050 affected31 at risk EG0060 affected31 at risk EG0073 affected32 at risk EG0082 affected30 at risk EG0091 affected31 at risk EG0100 affected1 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected8 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0023 affected8 at risk EG003
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0020 affected8 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected8 at risk EG003
Inflammation	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0021 affected8 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0022 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0021 affected8 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0025 affected8 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hyperleukocytosis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Monocytosis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Neutrophilia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Eye discharge	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0024 affected8 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0024 affected8 at risk EG003
Chest discomfort	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Face oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Gait disturbance	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hyperthermia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Mucosal inflammation	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected8 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rhinitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Sinusitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Tooth infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Tooth avulsion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Amylase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Blood uric acid increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
C-reactive protein increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lipase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Neutrophil count increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Platelet count increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Transaminases increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Weight increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected8 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Amnesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Aphasia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Monoparesis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Sciatica	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Syncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Agitation	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Distractibility	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Ketonuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected8 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0021 affected8 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected8 at risk EG003
White coat hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected8 at risk EG003

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases