Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxe... | NCT04655976

NCT04655976

ID	Type	Description	Link
2020-003433-37	EudraCT Number

Status Module

Label	Type	Intervention Names
Participants receiving cobolimab+ dostarlimab+ docetaxel	Experimental	Biological: Cobolimab Biological: Dostarlimab Drug: Docetaxel
Participants receiving dostarlimab+ docetaxel	Experimental	Biological: Dostarlimab Drug: Docetaxel
Participants receiving docetaxel	Active Comparator	Drug: Docetaxel

Name	Type	Description	Arm Group Labels	Other Names
Cobolimab	Biological	Cobolimab will be administered.	Participants receiving cobolimab+ dostarlimab+ docetaxel

Measure	Description	Time Frame
Overall Survival (OS) (Arm A Versus Arm C)	OS is defined as the time from the date of randomization to the date of death due to any cause.	Up to approximately 234 weeks
Overall Survival (OS) (Arm B Versus Arm C)	OS is defined as the time from the date of randomization to the date of death due to any cause.	Up to approximately 234 weeks

Measure	Description	Time Frame
Overall Survival (OS) (Arm A Versus Arm B)	OS is defined as the time from the date of randomization to the date of death due to any cause.	Up to approximately 234 weeks
Overall Response Rate (ORR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.
Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.
Participant has measurable disease.
Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.
Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
Participant has an ECOG performance status score of 0 or 1.
Participant has a life expectancy of at least 3 months.
Participant has adequate Baseline organ function.
Participant has recovered from any prior treatment related toxicities.
Participant agrees to use contraception.

Exclusion Criteria:

Participant has been previously treated with an anti-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an AE.
Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.
Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
Participant has received radiation to the lung that is >30 gray (Gy) within 6 months prior to the first dose of study treatment.
Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment).
Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.
Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment.
Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible.
Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management.
Participant has pre-existing peripheral neuropathy that is Grade >=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria.
Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.
Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose <=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Fountain Valley	California	92708	United States
GSK Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 4, 2025	Jun 5, 2026

Arm/Group Information

ID	Title	Description
BG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
BG001	Dostarlimab + Docetaxel (Arm B)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
BG002	Docetaxel (Arm C)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
BG003	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

Primary

Overall Survival (OS) (Arm A Versus Arm C)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Intent-to-Treat (ITT) population included all participants who were randomized into the study. As pre-specified in the protocol, the comparison of data was performed only between Arm A versus Arm C.

Posted

Median

95% Confidence Interval

Months

Up to approximately 234 weeks

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Docetaxel (Arm C)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Units	Counts
Participants	OG000305 OG001152

Title

Denominators

Categories

Title	Measurements
	OG00011.9(10.6 to 14.2) OG00111.3(9.5 to 13.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		One-sided stratified log rank		0.079708		Hazard Ratio (HR)	0.85			2-Sided	95	0.68	1.06			HR was estimated using stratified cox proportional hazards model, and stratified based on following factors: prior lines of therapy (1 prior line vs 2 prior lines), PD-L1 status (TPS ≥50% vs TPS <50%), and histology (squamous vs nonsquamous).		Superiority

Primary

Overall Survival (OS) (Arm B Versus Arm C)

OS is defined as the time from the date of randomization to the date of death due to any cause.

ITT population included all participants who were randomized into the study. As pre-specified in the protocol, the comparison of data was performed only between Arm B versus Arm C.

Posted

Median

95% Confidence Interval

Months

Up to approximately 234 weeks

ID	Title	Description
OG000	Dostarlimab + Docetaxel (Arm B)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Docetaxel (Arm C)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Units	Counts

Secondary

Overall Survival (OS) (Arm A Versus Arm B)

OS is defined as the time from the date of randomization to the date of death due to any cause.

ITT population included all participants who were randomized into the study. As pre-specified in the protocol, the comparison of data was performed only between Arm A versus Arm B.

Posted

Median

95% Confidence Interval

Months

Up to approximately 234 weeks

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Dostarlimab + Docetaxel (Arm B)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Secondary

Overall Response Rate (ORR)

ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) as the best overall response based on Investigator assessment, evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 . PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm).

ITT population

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 234 weeks

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Dostarlimab + Docetaxel (Arm B)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Secondary

Progression Free Survival (PFS)

PFS is defined as the length of time from randomization to the earliest date of assessment of disease progression based on RECIST v1.1 by Investigator assessment or death by any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start. In addition, the sum has an absolute increase from nadir of 5 mm.)

ITT population

Posted

Median

95% Confidence Interval

Months

Up to approximately 234 weeks

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Dostarlimab + Docetaxel (Arm B)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Secondary

Duration of Response (DOR)

DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).

ITT population. Only participants who achieved confirmed CR or PR as the best overall response is reported for this outcome measure.

Posted

Median

95% Confidence Interval

Months

Up to approximately 234 weeks

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Secondary

Time to Deterioration (TTD) in Lung Cancer

TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC-QLQ-LC13).

ITT population

Posted

Median

95% Confidence Interval

Months

Up to approximately 234 weeks

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Dostarlimab + Docetaxel (Arm B)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Secondary

Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These include five functional scales (physical functioning [PF], role functioning [RF], emotional functioning [EF] cognitive functioning [CF] and social functioning [SF]), three symptom scales (fatigue, nausea/vomiting [N/V] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss [AL], constipation, diarrhea and financial difficulties [FD]). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

ITT population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. Rows and Arms/Groups with 0 participants analyzed represent time points at which no participant data was available from within the respective Arms/Groups.

Posted

Mean

Standard Deviation

Scores on Scale

Baseline [Day(D) -1],D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)

ID	Title	Description
OG000

Secondary

Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment

The QLQ-LC13 questionnaire comprises 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain which includes pain in chest, pain in arm or shoulder and pain in other parts), and treatment-related side effects (sore mouth [SM], dysphagia, peripheral neuropathy [PN] and alopecia). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100. Higher scores represent increasing symptom levels. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Posted

Mean

Standard Deviation

Scores on Scale

Baseline (D -1),D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

Secondary

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings

ECGs were recorded after the participants were in a supine or semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes. ECG findings are summarized as clinically significant change from baseline worst case hierarchy: Yes > No > Not Applicable (NA).

Safety (SAF) population included all participants who received at least 1 dose of study treatment. ECGs after baseline were carried out only when clinically necessary, resulting in limited post-baseline data; only participants with available post-baseline ECGs were included in the Overall Number of Participants Analyzed.

Posted

Count of Participants

Participants

Baseline (Day-1) up to Cycle 1 Day 1

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Dostarlimab + Docetaxel (Arm B)

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Immune-mediate AEs (imAEs)

A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants With TEAEs Leading to Death and Treatment Discontinuation

A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants Using Concomitant Medications

Number of participants using concomitant medications will be presented.

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

Blood samples will be collected for the analysis of hematology parameters.

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples will be collected for the analysis of Clinical Chemistry parameters.

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants With Worst Case Thyroid Function Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples will be collected for the analysis of thyroid function

Not Posted

Up to 329 weeks

Participants

Secondary

Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline

Urine samples will be collected to analyze urine specific gravity.

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants With Worst Case Vital Signs Results Relative to Normal Range Post-Baseline Relative to Baseline

Vital signs will be assessed

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Vital Signs

Vital signs will be assessed and presented

Not Posted

Apr 2027

Baseline (Day -1) and Up to 281 weeks

Participants

Secondary

Number of Participants With Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status

Performance status will be assessed using the ECOG performance status scale.

Not Posted

Mar 2028

Up to 329 weeks

Participants

Secondary

Number of Participants With Abnormal Physical Examinations

Number of participants with abnormal physical examinations will be presented

As pre-specified in the Statistical Analysis Plan, no planned analysis was generated for physical examination, and thus no data was collected in the eCRF or captured in the clinical database.

Posted

Up to approximately 234 weeks

ID	Title	Description
OG000	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
OG001	Docetaxel (Arm C)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.

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	Cobolimab + Dostarlimab + Docetaxel (Arm A)	Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.	227	305	102	302	285	302
EG001	Dostarlimab + Docetaxel (Arm B)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.	236	301	126	295	276	295
EG002	Docetaxel (Arm C)	Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.	116	152	52	144	136	144

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected302 at risk EG0011 events1 affected295 at risk EG0023 events2 affected144 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0009 events9 affected302 at risk EG00116 events15 affected295 at risk EG0022 events2 affected144 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected302 at risk EG0015 events5 affected295 at risk EG0021 events1 affected144 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected302 at risk EG0013 events3 affected295 at risk EG0021 events1 affected144 at risk
Atrial flutter	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Cardiac arrest	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Cardiac failure	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Pericardial effusion	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Diabetes insipidus	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Glucocorticoid deficiency	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Immune-mediated hypophysitis	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Uveitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Colitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0013 events2 affected295 at risk EG0021 events1 affected144 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Enteritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Gastritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Terminal ileitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected295 at risk EG0021 events1 affected144 at risk
Catheter site pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
General physical health deterioration	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0021 events1 affected144 at risk
Generalised oedema	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Inflammation	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Mucosal inflammation	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Non-cardiac chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0013 events3 affected295 at risk EG0021 events1 affected144 at risk
Ulcer haemorrhage	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Anal abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Bacteraemia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Bronchitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0014 events4 affected295 at risk EG0020 events0 affected144 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0014 events4 affected295 at risk EG0020 events0 affected144 at risk
Catheter site infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Cellulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Diverticulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Diverticulitis intestinal perforated	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Febrile infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Furuncle	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0014 events4 affected295 at risk EG0021 events1 affected144 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0022 events2 affected144 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Peritonitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0021 events1 affected144 at risk
Pharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0021 events1 affected144 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00022 events19 affected302 at risk EG00129 events24 affected295 at risk EG00213 events12 affected144 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Pneumonia fungal	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Pneumonia viral	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Post procedural sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Prostatitis Escherichia coli	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Pseudomonas infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected302 at risk EG0012 events2 affected295 at risk EG0022 events2 affected144 at risk
Sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0013 events3 affected295 at risk EG0021 events1 affected144 at risk
Septic shock	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Skin infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0021 events1 affected144 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
C-reactive protein increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0014 events4 affected295 at risk EG0020 events0 affected144 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events1 affected295 at risk EG0020 events0 affected144 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Nasal cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Aphasia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Spinal cord compression	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Confusional state	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Delirium	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Depression	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected295 at risk EG0021 events1 affected144 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Immune-mediated nephritis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Renal failure	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Urinary retention	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0021 events1 affected144 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0013 events3 affected295 at risk EG0020 events0 affected144 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected302 at risk EG0015 events3 affected295 at risk EG0024 events4 affected144 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected302 at risk EG0014 events4 affected295 at risk EG0020 events0 affected144 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0022 events1 affected144 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0016 events5 affected295 at risk EG0021 events1 affected144 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected302 at risk EG0016 events6 affected295 at risk EG0021 events1 affected144 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events5 affected302 at risk EG0012 events2 affected295 at risk EG0020 events0 affected144 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0014 events4 affected295 at risk EG0021 events1 affected144 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0010 events0 affected295 at risk EG0020 events0 affected144 at risk
Aortic thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Hypotension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0012 events2 affected295 at risk EG0021 events1 affected144 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0010 events0 affected295 at risk EG0021 events1 affected144 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected302 at risk EG0011 events1 affected295 at risk EG0020 events0 affected144 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG000165 events105 affected302 at risk EG001149 events93 affected295 at risk EG00266 events41 affected144 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00028 events25 affected302 at risk EG00118 events16 affected295 at risk EG00215 events14 affected144 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG000122 events95 affected302 at risk EG00196 events77 affected295 at risk EG00260 events38 affected144 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00018 events17 affected302 at risk EG00122 events18 affected295 at risk EG0023 events3 affected144 at risk
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00048 events39 affected302 at risk EG00153 events40 affected295 at risk EG00221 events18 affected144 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG000137 events87 affected302 at risk EG001129 events87 affected295 at risk EG00257 events37 affected144 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00092 events74 affected302 at risk EG00198 events68 affected295 at risk EG00245 events30 affected144 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00026 events19 affected302 at risk EG00134 events27 affected295 at risk EG00214 events11 affected144 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00036 events32 affected302 at risk EG00143 events32 affected295 at risk EG00213 events10 affected144 at risk
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG000127 events70 affected302 at risk EG001141 events79 affected295 at risk EG00261 events36 affected144 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG000147 events89 affected302 at risk EG001158 events88 affected295 at risk EG00261 events40 affected144 at risk
Mucosal inflammation	General disorders	MedDRA 28.0	Systematic Assessment	EG00045 events36 affected302 at risk EG00127 events22 affected295 at risk EG00214 events12 affected144 at risk
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG00039 events27 affected302 at risk EG00122 events21 affected295 at risk EG00219 events16 affected144 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG00042 events31 affected302 at risk EG00138 events27 affected295 at risk EG00217 events12 affected144 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00032 events30 affected302 at risk EG00118 events18 affected295 at risk EG0029 events8 affected144 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00016 events13 affected302 at risk EG00131 events23 affected295 at risk EG0027 events7 affected144 at risk
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00017 events13 affected302 at risk EG00127 events18 affected295 at risk EG00210 events6 affected144 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00017 events13 affected302 at risk EG00128 events17 affected295 at risk EG0028 events6 affected144 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00019 events12 affected302 at risk EG00125 events16 affected295 at risk EG0026 events6 affected144 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00019 events16 affected302 at risk EG00116 events13 affected295 at risk EG0029 events5 affected144 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG00032 events21 affected302 at risk EG00115 events11 affected295 at risk EG00215 events11 affected144 at risk
Neutrophil count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00095 events44 affected302 at risk EG00151 events44 affected295 at risk EG00230 events21 affected144 at risk
White blood cell count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG00073 events28 affected302 at risk EG00145 events31 affected295 at risk EG00221 events15 affected144 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00077 events61 affected302 at risk EG00193 events69 affected295 at risk EG00233 events27 affected144 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00046 events15 affected302 at risk EG00120 events15 affected295 at risk EG00211 events8 affected144 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG00024 events18 affected302 at risk EG00110 events8 affected295 at risk EG0027 events6 affected144 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00071 events46 affected302 at risk EG00151 events40 affected295 at risk EG00211 events8 affected144 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00020 events19 affected302 at risk EG00129 events28 affected295 at risk EG0026 events6 affected144 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00035 events30 affected302 at risk EG00160 events44 affected295 at risk EG00220 events18 affected144 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00019 events16 affected302 at risk EG00112 events12 affected295 at risk EG0024 events4 affected144 at risk
Dysgeusia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00014 events10 affected302 at risk EG00128 events23 affected295 at risk EG0027 events7 affected144 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00020 events17 affected302 at risk EG00122 events16 affected295 at risk EG0025 events5 affected144 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00055 events35 affected302 at risk EG00140 events29 affected295 at risk EG00232 events24 affected144 at risk
Paraesthesia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00027 events20 affected302 at risk EG00118 events12 affected295 at risk EG0024 events4 affected144 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG00025 events21 affected302 at risk EG00128 events20 affected295 at risk EG0024 events3 affected144 at risk
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG00024 events21 affected302 at risk EG00121 events19 affected295 at risk EG0027 events7 affected144 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00054 events44 affected302 at risk EG00158 events48 affected295 at risk EG00219 events17 affected144 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00070 events52 affected302 at risk EG00163 events51 affected295 at risk EG00237 events27 affected144 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG00016 events10 affected302 at risk EG00122 events16 affected295 at risk EG0022 events2 affected144 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG00090 events78 affected302 at risk EG00179 events69 affected295 at risk EG00242 events40 affected144 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG00055 events33 affected302 at risk EG00144 events38 affected295 at risk EG00212 events7 affected144 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG00046 events33 affected302 at risk EG00141 events30 affected295 at risk EG0029 events7 affected144 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes