Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Avelumab

Cisplatin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.

Participants received Pemetrexed 500 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Participants received Paclitaxel 200 mg/m\^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Participants received Gemcitabine 1250 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.

Participants received Gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.

Participants received Carboplatin area under concentration curve (AUC) 5 mg/mL\*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.

Participants received Cisplatin 75 mg/m\^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Carboplatin AUC 6 mg/mL\*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.

Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks.

Avelumab Weekly

Medical Responsible

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Avelumab in First-line NSCLC (JAVELIN Lung 100)

A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAEs were those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period TEAEs included both serious TEAEs and non-serious TEAEs. Any AE that was suspicious to be a potential Immune-related adverse event (irAE) including infusion related reactions were considered AESIs. Number of participants with TEAEs and AESIs were reported.

Number of participants with shifts from Baseline values (Grade 0/1/2/3) to abnormal post-baseline values (shift to \>= Grade 4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in laboratory parameter (anemia, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, white blood cell count decreased, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased and Hyperglycemia) were reported.

The number of participants with changes from baseline in increased Body Temperature (degree Celsius \[°C\]) were reported by using criteria: Baseline temperature (temp.) less than (\<) 37°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, greater than or equal to (\>=)3°C and missing; Baseline temp. 37 - \<38°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 38 - \<39°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. 39-\<40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. \>=40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C, \>=3°C and missing; Baseline temp. missing, on treatment change missing.

The number of participants with maximal on-treatment changes from baseline in Increase (Ic.)/Decrease (Dc.) in maximal weight were reported by using criteria: Ic./Dc. From baseline, on treatment (TR) change \<10 percentage (%), \>=10% and missing.

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) heart rate (HR) (beats per minute \[bpm\]) were reported by using criteria: Ic./Dc. BS HR \<100/\>=100 bpm, on treatment change =\<20 bpm, \>20 - =\<40 bpm, \>40 bpm and missing; Ic./Dc. BS HR missing, on treatment change missing.

The number of participants with maximal on-treatment changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) (millimeter of mercury \[mmHg\]) were reported by using criteria: Ic./Dc. BS SBP \<140 mmHg and \>=140 mmHg, on maximal treatment (TR) change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS SBP missing, on maximal treatment (TR) change missing; Ic./Dc. BS DBP \<90 mmHg and \>= 90 mmHg, on maximal TR change =\<20 mmHg, \>20 - =\<40 mmHg, \>40 mmHg and missing; Ic./Dc. BS DBP missing on maximal TR change missing.

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR \<20 breaths per minute (breaths/min), on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing. Ic./Dc. BS RR missing, on TR change missing. Ic./Dc. BS RR \>=20 breaths/min, on TR change =\<5 breaths/min, \>5 - =\<10 breaths/min, \>10 breaths/min and missing.

ECG parameters included heart rate, PR interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). PCSA criteria for abnormal value of ECG parameters: any heart rate \<= 50 bpm and decrease from baseline \>=20 bpm , any hear rate \>= 120 bpm and increase from baseline \>= 20 bpm; PR interval: \>= 220 milliseconds (ms) and increase from baseline \>= 20 ms; QRS interval \>= 120 ms; QTcF \> 450 ms, \> 480 ms, \> 500 ms, QTcF increase from baseline \> 30 ms and QTcF increase from baseline \> 60 ms; QTcB \> 450 ms, \> 480 ms, \> 500 ms, QTcB increase from baseline \> 30 ms and QTcB increase from baseline \> 60 ms.

ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with baseline value vs worst post-baseline value (that is \[i.e.\] highest score).

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Only participants who received study medication were included in the analysis of adverse events. All randomized participants were included in the analysis of all-cause mortality.

Avelumab Biweekly

Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks, followed by Avelumab at a dose of 10 mg/kg once every 2 weeks until disease progression or unacceptable toxicities.

Participants with tumor of nonsquamous histology received Pemetrexed (500 milligrams per square meter \[mg/m\^2\]) in combination with Cisplatin (75 mg/m\^2) administered on Day 1 of each cycle or pemetrexed (500 mg/m\^2) in combination with carboplatin (area under the concentration curve \[AUC\] 6 milligrams per milliliter \[mg/mL\] \* minutes \[min\] administered on Day 1 of each cycle). Participants who were assigned pemetrexed could continue to receive pemetrexed as a maintenance therapy after 4 cycles of platinum-based chemotherapy if their disease had not progressed, or in accordance with pemetrexed local label. Participants with tumor of squamous histology received Paclitaxel (200 mg/m\^2) plus carboplatin (AUC 6 mg/mL \* min administered on Day 1 of each cycle) or Gemcitabine (1250 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus cisplatin (75 mg/m\^2) or Gemcitabine (1000 mg/m\^2 administered on Day 1 and Day 8 of each cycle) plus carboplatin (AUC 5 mg/mL \* min) in 3-week cycles up to a maximum of 6 cycles of IV injection or until disease progression or unacceptable toxicities.

Chemotherapy

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Communication Center

High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. High expression PD-L1+ participants with greater than or equal to (\>=) 80 percent (%) of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly Avelumab was included into the randomization allocation. The PDL1+ participants with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)

Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

Moderate and High PD-L1+ FAS included all high expression PDL-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

Moderate and High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

Moderate and High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

FAS included all participants who were randomized to study intervention.

Overall Survival (OS) in Full Analysis Set (FAS)

mFAS included all participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation.

Overall Survival (OS) in Modified Full Analysis Set (mFAS)

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Modified Full Analysis Set

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Full Analysis Set

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Modified Full Analysis Set

High PD-L1+ FAS was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

High PD-L1+ mFAS was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

High PD-L1+HRQoL analysis set includes all high expression PD-L1+ FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High PD-L1+ Health-related Quality of Life (HRQoL) Analysis Set at End of Treatment

High PD-L1+ Modified HRQoL Analysis Set included all mFAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire completed. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set

High PD-L1+HRQoL analysis set includes all high expression PD-L1 FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+).

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set

High PD-L1+modified HRQoL analysis set includes all high expression PD-l1+ mFAS participants who have 1 baseline HRQoL assessment and have ≥1 post-baseline HRQoL questionnaire completed. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set

Dyspnea

Coughing

Hemoptysis

Sore mouth

Dysphagia

Peripheral neuropathy

Alopecia

Pain in chest

Pain in arm or shoulder

Pain in other parts

High PD-L1+ HRQoL analysis set includes all high expression PD-L1+ FAS participants who have 1 baseline HRQoL assessment and have \>=1 post-baseline HRQoL questionnaire complete. The high expression PDL1+ participants were with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set

High PD-L1+ modified HRQoL analysis set was used. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for specified categories.

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set

TEAEs

AESIs

The Safety analysis set (Safety-AS) included all randomized participants who were administered at least one dose of the study medication, that is (i.e.) avelumab or chemotherapy.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs)

Anemia: Grade 0 to Grade 3

Anemia: Grade 1 to Grade 3

Anemia: Grade 2 to Grade 3

Lymphocyte count decreased: Grade 0 to Grade 3

Lymphocyte count decreased: Grade 0 to Grade 4

Lymphocyte count decreased: Grade 1 to Grade 3

Lymphocyte count decreased: Grade 2 to Grade 3

Lymphocyte count decreased: Grade 2 to Grade 4

Lymphocyte count decreased: Grade 3 to Grade 4

Neutrophil count decreased: Grade 0 to Grade 3

Neutrophil count decreased: Grade 0 to Grade 4

Neutrophil count decreased: Grade 1 to Grade 3

Platelet count decreased: Grade 0 to Grade 3

Platelet count decreased: Grade 0 to Grade 4

Platelet count decreased: Grade 1 to Grade 3

White blood cell count decreased: Grade 0 to Grade 3

White blood cell count decreased: Grade 0 to Grade 4

Alanine aminotransferase increased: Grade 0 to Grade 3

Alanine aminotransferase increased: Grade 0 to Grade 4

Alanine aminotransferase increased: Grade 1 to Grade 3

Alkaline phosphatase increased: Grade 0 to Grade 3

Alkaline phosphatase increased: Grade 1 to Grade 3

Alkaline phosphatase increased: Grade 1 to Grade 4

Alkaline phosphatase increased: Grade 2 to Grade 3

Aspartate aminotransferase increased: Grade 0 to Grade 3

Aspartate aminotransferase increased: Grade 0 to Grade 4

Aspartate aminotransferase increased: Grade 1 to Grade 3

Blood bilirubin increased: Grade 0 to Grade 3

Blood bilirubin increased: Grade 0 to Grade 4

Creatine phosphokinase increased: Grade 0 to Grade 3

Creatine phosphokinase increased: Grade 0 to Grade 4

Creatine phosphokinase increased: Grade 1 to Grade 4

Creatine phosphokinase increased: Grade 2 to Grade 3

Creatinine increased: Grade 0 to Grade 3

Creatinine increased: Grade 1 to Grade 3

Hyperglycemia: Grade 0 to Grade 3

Hyperglycemia: Grade 0 to Grade 4

Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Spots Global Cancer Trial Database for avelumab weekly