Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction
Conditions
Keywords
Avelumab, Cancer, Unresectable, Locally advanced, Metastatic, Adenocarcinoma of the stomach, Gastro-esophageal junction
Brief summary
The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.
Interventions
DRUGLeucovorin
Induction Phase: Leucovorin was administered at a dose of 200 mg/m\^2 IV (or) Leucovorin 400 mg/m\^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.
DRUGAvelumab
Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.
DRUGOxaliplatin
Induction Phase: Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.
DRUG5-Fluorouracil
Induction Phase: 5-Fluorouracil was administered at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.
DRUGCapecitabine
Induction Phase: Capecitabine was administered at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase every 3 weeks until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.
OTHERBest supportive care
Treatment administered with the intent to maximize Quality of Life (QoL) without a specific antineoplastic regimen. These may include for example antibiotics, analgesics, antiemetics, thoracentesis, paracentesis, blood transfusions, nutritional support (including jejunostomy), and focal external-beam radiation for control of pain, cough, dyspnea, or bleeding. Best supportive care were administered per institutional guidelines and participants were visit the clinic every 3 weeks.
Sponsors
Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants greater than or equal to (\>=) 18 years * Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) * Participants with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry * Estimated life expectancy of more than 12 weeks * Adequate haematological, hepatic and renal functions defined by the protocol * Negative blood pregnancy test at Screening for women of childbearing potential * Highly effective contraception for both male and female participants if the risk of conception exists * Other protocol defined inclusion criteria could apply
Exclusion criteria
* Prior therapy with any antibody or drug targeting T-cell coregulatory proteins * Concurrent anticancer treatment or immunosuppressive agents * Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) * Tumor shown to be human epidermal growth factor 2 plus (HER2+) * Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the participant has not fully recovered from the surgery within 4 weeks of enrolment * Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of participants with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to \<= 10 mg prednisone daily) * All participants with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, have not been progressing at least 2 months after completion of therapy, and no steroid maintenance therapy is required, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) * Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast) * Prior organ transplantation, including allogeneic stem-cell transplantation * Significant acute or chronic infections * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent * Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) * Persisting toxicity related to prior therapy except alopecia * Neuropathy Grade \> 3 * Pregnancy or lactation * Known alcohol or drug abuse * History of uncontrolled intercurrent illness including hypertension, active infection, diabetes * Clinically significant (i.e., active) cardiovascular disease * All other significant diseases might impair the participant's tolerance of study treatment * Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements * Vaccination with live or live/attenuated viruses within 55 days of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines * Legal incapacity or limited legal capacity * Participants will be excluded from the Induction Phase and the Maintenance Phase if administration of their chemotherapy would be inconsistent with the current local labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or special provisions) for that chemotherapy. Investigators should check updated labelling via relevant websites at the time of entry into the Induction Phase and the Maintenance Phase * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization into maintenance phase up to 1276 days | Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response (BOR) by Investigator Assessment | From randomization into maintenance phase up to 1276 days | BOR was determined by RECIST v1.1 per Investigator assessment and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD equal to progression \<=2 weeks after date of randomization. |
| Objective Response Rate (ORR) by Investigator Assessment | From randomization into maintenance phase up to 1276 days | The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. |
| Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | 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 composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state. |
| Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | 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. |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is 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, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. |
| Progression Free Survival (PFS) by Independent Review Committee (IRC) | From randomization into maintenance phase up to 1276 days | The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of 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. |
| Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | From randomization into maintenance phase up to 1276 days | 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 TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported. |
| Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | From baseline up to 1276 days | Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented. |
| Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | From randomization into maintenance phase up to 1276 days | Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator. |
| Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | From randomization into maintenance phase up to 1276 days | ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported. |
| Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 | From randomization into maintenance phase up to 1276 days | ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported. |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. |
Countries
Australia, Brazil, Canada, France, Germany, Hungary, Italy, Japan, Romania, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
Overall, 1284 participants were screened for this study. Of which 799 participants received at least 1 dose in the Induction Phase, 499 participants were randomized into maintenance phase of the study.
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy + Best Supportive Care (BSC) Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion. | 250 |
| Avelumab Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase.
In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. | 249 |
| Total | 499 |
Baseline characteristics
| Characteristic | Total | Avelumab | Chemotherapy + Best Supportive Care (BSC) |
|---|---|---|---|
| Age, Continuous | 60.7 Years STANDARD_DEVIATION 11.36 | 60.7 Years STANDARD_DEVIATION 11.03 | 60.6 Years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 19 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 433 Participants | 220 Participants | 213 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 32 Participants | 10 Participants | 22 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 120 Participants | 61 Participants | 59 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not collected at this site | 34 Participants | 12 Participants | 22 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 332 Participants | 171 Participants | 161 Participants |
| Sex: Female, Male Female | 168 Participants | 85 Participants | 83 Participants |
| Sex: Female, Male Male | 331 Participants | 164 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 238 | 16 / 243 |
| other Total, other adverse events | 203 / 238 | 191 / 243 |
| serious Total, serious adverse events | 75 / 238 | 89 / 243 |
Outcome results
Primary
Overall Survival (OS)
Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Overall Survival (OS) | 10.9 months |
| Avelumab | Overall Survival (OS) | 10.4 months |
p-value: 0.177995% CI: [0.74, 1.11]Log Rank
Secondary
Best Overall Response (BOR) by Investigator Assessment
BOR was determined by RECIST v1.1 per Investigator assessment and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD equal to progression \<=2 weeks after date of randomization.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Best Overall Response (BOR) by Investigator Assessment | Complete response | 5 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Best Overall Response (BOR) by Investigator Assessment | Partial response | 31 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Best Overall Response (BOR) by Investigator Assessment | Stable disease | 117 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Best Overall Response (BOR) by Investigator Assessment | Noncomplete response/non progressive disease | 11 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Best Overall Response (BOR) by Investigator Assessment | Progressive disease | 58 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Best Overall Response (BOR) by Investigator Assessment | Non evaluable | 28 Participants |
| Avelumab | Best Overall Response (BOR) by Investigator Assessment | Progressive disease | 85 Participants |
| Avelumab | Best Overall Response (BOR) by Investigator Assessment | Complete response | 8 Participants |
| Avelumab | Best Overall Response (BOR) by Investigator Assessment | Noncomplete response/non progressive disease | 10 Participants |
| Avelumab | Best Overall Response (BOR) by Investigator Assessment | Partial response | 25 Participants |
| Avelumab | Best Overall Response (BOR) by Investigator Assessment | Non evaluable | 29 Participants |
| Avelumab | Best Overall Response (BOR) by Investigator Assessment | Stable disease | 92 Participants |
Secondary
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks)
European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is 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, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Time frame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Population: Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 3/4 | 1.30 units on a scale | Standard Deviation 15.486 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 7 | -1.44 units on a scale | Standard Deviation 14.905 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 13 | -2.50 units on a scale | Standard Deviation 15.424 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 19 | -5.85 units on a scale | Standard Deviation 18.363 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 25 | -4.43 units on a scale | Standard Deviation 15.407 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 31 | -3.09 units on a scale | Standard Deviation 19.902 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 37 | -1.39 units on a scale | Standard Deviation 22.186 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 43 | -1.19 units on a scale | Standard Deviation 12.167 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 49 | 1.52 units on a scale | Standard Deviation 9.731 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 55 | 0.00 units on a scale | Standard Deviation 11.785 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 61 | -5.00 units on a scale | Standard Deviation 13.944 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 67 | 0.00 units on a scale | Standard Deviation 9.129 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | End Of Treatment | -11.54 units on a scale | Standard Deviation 23.46 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Safety Follow-Up | -7.51 units on a scale | Standard Deviation 19.475 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 61 | 2.38 units on a scale | Standard Deviation 15.622 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 3/4 | 0.85 units on a scale | Standard Deviation 15.021 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 43 | 3.33 units on a scale | Standard Deviation 18.518 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 7 | -1.01 units on a scale | Standard Deviation 16.967 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | End Of Treatment | -11.67 units on a scale | Standard Deviation 21.409 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 13 | 0.24 units on a scale | Standard Deviation 17.637 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 49 | 4.01 units on a scale | Standard Deviation 15.907 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 19 | 1.37 units on a scale | Standard Deviation 18.611 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 67 | 4.90 units on a scale | Standard Deviation 18.413 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 25 | 0.41 units on a scale | Standard Deviation 16.204 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 55 | 4.00 units on a scale | Standard Deviation 15.426 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 31 | 1.85 units on a scale | Standard Deviation 16.938 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Safety Follow-Up | -9.29 units on a scale | Standard Deviation 24.881 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 37 | 1.77 units on a scale | Standard Deviation 19.293 |
Secondary
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.
Time frame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Population: Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 31 | 4.01 units on a scale | Standard Deviation 19.111 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 61 | 0.00 units on a scale | Standard Deviation 15.713 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 43 | -4.76 units on a scale | Standard Deviation 14.265 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 49 | -3.03 units on a scale | Standard Deviation 8.736 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 55 | 0.00 units on a scale | Standard Deviation 13.608 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia: Week 3/4 | 0.76 units on a scale | Standard Deviation 13.371 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 7 | 2.84 units on a scale | Standard Deviation 15.258 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 13 | 1.60 units on a scale | Standard Deviation 14.09 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 19 | -0.58 units on a scale | Standard Deviation 15.772 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 25 | -1.39 units on a scale | Standard Deviation 10.465 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 31 | 0.82 units on a scale | Standard Deviation 14.755 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 37 | -7.19 units on a scale | Standard Deviation 17.977 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 67 | -1.85 units on a scale | Standard Deviation 10.924 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia End Of Treatment | 7.27 units on a scale | Standard Deviation 25.134 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Safety Follow-Up | 9.39 units on a scale | Standard Deviation 21.467 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 3/4 | 1.51 units on a scale | Standard Deviation 13.013 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 7 | 2.53 units on a scale | Standard Deviation 15.351 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 13 | 2.96 units on a scale | Standard Deviation 14.585 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 19 | 3.22 units on a scale | Standard Deviation 14.152 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 37 | -4.90 units on a scale | Standard Deviation 19.777 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 43 | 1.79 units on a scale | Standard Deviation 18.251 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 49 | 1.52 units on a scale | Standard Deviation 5.025 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 55 | 0.00 units on a scale | Standard Deviation 19.543 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 61 | 3.33 units on a scale | Standard Deviation 9.501 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 67 | 0.00 units on a scale | Standard Deviation 12.91 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain End Of Treatment | 9.25 units on a scale | Standard Deviation 20.853 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Safety Follow-Up | 8.22 units on a scale | Standard Deviation 18.011 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 3/4 | 1.04 units on a scale | Standard Deviation 14.197 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 7 | 0.31 units on a scale | Standard Deviation 14.695 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 13 | 0.99 units on a scale | Standard Deviation 14.098 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 19 | 1.75 units on a scale | Standard Deviation 17.032 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 25 | 0.69 units on a scale | Standard Deviation 14.648 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 31 | -2.06 units on a scale | Standard Deviation 14.791 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 37 | -6.54 units on a scale | Standard Deviation 18.864 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 43 | -3.17 units on a scale | Standard Deviation 15.364 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 49 | 1.01 units on a scale | Standard Deviation 9.236 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 55 | 2.22 units on a scale | Standard Deviation 4.969 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 61 | 6.67 units on a scale | Standard Deviation 9.938 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 67 | 7.41 units on a scale | Standard Deviation 13.456 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux End of Treatment | 3.43 units on a scale | Standard Deviation 19.529 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Safety Follow-up | 1.56 units on a scale | Standard Deviation 20.254 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 3/4 | 0.73 units on a scale | Standard Deviation 16.279 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 7 | 0.98 units on a scale | Standard Deviation 16.123 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 13 | 1.02 units on a scale | Standard Deviation 14.234 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 19 | -2.34 units on a scale | Standard Deviation 16.648 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 25 | -2.08 units on a scale | Standard Deviation 18.208 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 31 | -2.47 units on a scale | Standard Deviation 15.814 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 37 | -8.82 units on a scale | Standard Deviation 21.943 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 43 | -4.76 units on a scale | Standard Deviation 18.115 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 49 | 0.76 units on a scale | Standard Deviation 11.459 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 55 | 3.33 units on a scale | Standard Deviation 15.138 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 61 | 0.00 units on a scale | Standard Deviation 15.59 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 67 | 1.39 units on a scale | Standard Deviation 13.351 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions EOT | 8.27 units on a scale | Standard Deviation 20.898 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Safety Follow-up | 7.04 units on a scale | Standard Deviation 24.055 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 3/4 | -0.28 units on a scale | Standard Deviation 16.15 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 7 | -1.30 units on a scale | Standard Deviation 16.947 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 25 | -1.56 units on a scale | Standard Deviation 13.789 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 13 | -0.86 units on a scale | Standard Deviation 20.685 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 19 | -1.56 units on a scale | Standard Deviation 21.561 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 25 | -2.78 units on a scale | Standard Deviation 23.78 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 31 | 4.12 units on a scale | Standard Deviation 23.7 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 37 | -3.92 units on a scale | Standard Deviation 20.765 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 43 | -3.97 units on a scale | Standard Deviation 22.48 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 49 | 0.00 units on a scale | Standard Deviation 12.172 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 55 | 2.22 units on a scale | Standard Deviation 9.296 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 61 | -4.44 units on a scale | Standard Deviation 12.669 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 67 | 9.26 units on a scale | Standard Deviation 16.355 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety End of Treatment | 4.58 units on a scale | Standard Deviation 21.868 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Safety Follow-Up | 5.48 units on a scale | Standard Deviation 24.116 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 49 | -2.06 units on a scale | Standard Deviation 16.317 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions EOT | 10.01 units on a scale | Standard Deviation 22.055 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 61 | 1.06 units on a scale | Standard Deviation 12.123 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 55 | -3.56 units on a scale | Standard Deviation 19.699 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 43 | -2.59 units on a scale | Standard Deviation 13.27 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 67 | -1.96 units on a scale | Standard Deviation 24.918 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 49 | 1.23 units on a scale | Standard Deviation 13.195 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 61 | -6.35 units on a scale | Standard Deviation 12.944 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Safety Follow-up | 11.59 units on a scale | Standard Deviation 25.05 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia: Week 3/4 | 0.60 units on a scale | Standard Deviation 15.227 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 67 | 0.00 units on a scale | Standard Deviation 19.245 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 7 | 1.34 units on a scale | Standard Deviation 13.453 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 43 | -1.11 units on a scale | Standard Deviation 24.474 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 13 | 0.65 units on a scale | Standard Deviation 12.781 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux End of Treatment | 4.73 units on a scale | Standard Deviation 20.455 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 19 | 1.52 units on a scale | Standard Deviation 14.307 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 3/4 | -4.06 units on a scale | Standard Deviation 18.03 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 25 | 1.69 units on a scale | Standard Deviation 14.852 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Safety Follow-up | 2.90 units on a scale | Standard Deviation 19.212 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 31 | 4.39 units on a scale | Standard Deviation 20.877 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 25 | -1.55 units on a scale | Standard Deviation 17.54 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 37 | -0.67 units on a scale | Standard Deviation 14.683 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 3/4 | 0.13 units on a scale | Standard Deviation 15.438 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 67 | 1.31 units on a scale | Standard Deviation 17.516 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 49 | -6.17 units on a scale | Standard Deviation 17.792 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia End Of Treatment | 8.21 units on a scale | Standard Deviation 22.633 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 7 | -0.27 units on a scale | Standard Deviation 15.516 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Safety Follow-Up | 7.25 units on a scale | Standard Deviation 19.417 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 7 | -1.20 units on a scale | Standard Deviation 20.58 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 3/4 | -0.04 units on a scale | Standard Deviation 13.465 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 13 | 0.00 units on a scale | Standard Deviation 14.023 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 7 | 2.60 units on a scale | Standard Deviation 15.21 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety End of Treatment | 5.89 units on a scale | Standard Deviation 23.939 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 13 | 0.16 units on a scale | Standard Deviation 13.523 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 19 | -0.63 units on a scale | Standard Deviation 11.993 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 19 | -0.51 units on a scale | Standard Deviation 14.088 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 31 | 0.97 units on a scale | Standard Deviation 18.564 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 13 | -2.83 units on a scale | Standard Deviation 16.3 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 37 | -1.26 units on a scale | Standard Deviation 12.346 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 25 | -1.55 units on a scale | Standard Deviation 15.434 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 43 | -1.94 units on a scale | Standard Deviation 14.129 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 55 | -4.00 units on a scale | Standard Deviation 20 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 49 | -0.62 units on a scale | Standard Deviation 12.853 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 31 | 0.39 units on a scale | Standard Deviation 14.88 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 55 | -1.00 units on a scale | Standard Deviation 10.012 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 19 | -1.68 units on a scale | Standard Deviation 19.22 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 61 | -1.59 units on a scale | Standard Deviation 13.596 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 37 | -3.28 units on a scale | Standard Deviation 15.014 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Week 67 | -0.49 units on a scale | Standard Deviation 15.721 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Dysphagia Week 55 | 0.89 units on a scale | Standard Deviation 13.194 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain End Of Treatment | 9.45 units on a scale | Standard Deviation 22.96 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 43 | -3.89 units on a scale | Standard Deviation 13.443 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Pain Safety Follow-Up | 10.99 units on a scale | Standard Deviation 20.931 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 25 | -1.69 units on a scale | Standard Deviation 14.562 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 3/4 | 0.12 units on a scale | Standard Deviation 13.571 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 49 | -5.25 units on a scale | Standard Deviation 12.043 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 7 | 0.50 units on a scale | Standard Deviation 17.807 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 61 | -4.76 units on a scale | Standard Deviation 24.488 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 13 | -1.09 units on a scale | Standard Deviation 15.753 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 55 | -6.00 units on a scale | Standard Deviation 12.62 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 19 | -1.68 units on a scale | Standard Deviation 15.377 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 31 | -0.52 units on a scale | Standard Deviation 24.119 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 25 | 1.69 units on a scale | Standard Deviation 19.77 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 61 | -5.56 units on a scale | Standard Deviation 12.999 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 31 | -1.29 units on a scale | Standard Deviation 18.339 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Safety Follow-Up | 4.99 units on a scale | Standard Deviation 26.234 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 37 | -4.38 units on a scale | Standard Deviation 17.773 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Eating Restrictions Week 67 | -2.45 units on a scale | Standard Deviation 19.712 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Reflux Week 43 | -5.56 units on a scale | Standard Deviation 16.699 |
| Avelumab | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | Anxiety Week 37 | -1.01 units on a scale | Standard Deviation 27.409 |
Secondary
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks)
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 composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state.
Time frame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Population: Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 3/4 | -0.002 Units on Scale | Standard Deviation 0.1242 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 7 | -0.032 Units on Scale | Standard Deviation 0.1644 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 13 | -0.053 Units on Scale | Standard Deviation 0.1733 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 19 | -0.039 Units on Scale | Standard Deviation 0.1934 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 25 | -0.049 Units on Scale | Standard Deviation 0.1797 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 31 | -0.023 Units on Scale | Standard Deviation 0.1619 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 37 | -0.035 Units on Scale | Standard Deviation 0.1505 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 43 | -0.046 Units on Scale | Standard Deviation 0.136 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 49 | -0.100 Units on Scale | Standard Deviation 0.1796 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 55 | -0.164 Units on Scale | Standard Deviation 0.2056 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 61 | -0.091 Units on Scale | Standard Deviation 0.2229 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 67 | -0.076 Units on Scale | Standard Deviation 0.2347 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | End Of Treatment | -0.125 Units on Scale | Standard Deviation 0.2432 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Safety Follow-Up | -0.062 Units on Scale | Standard Deviation 0.2391 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 61 | 0.031 Units on Scale | Standard Deviation 0.1364 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 3/4 | 0.004 Units on Scale | Standard Deviation 0.161 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 43 | 0.058 Units on Scale | Standard Deviation 0.199 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 7 | -0.009 Units on Scale | Standard Deviation 0.1588 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | End Of Treatment | -0.138 Units on Scale | Standard Deviation 0.2461 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 13 | -0.017 Units on Scale | Standard Deviation 0.1599 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 49 | 0.026 Units on Scale | Standard Deviation 0.1936 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 19 | -0.011 Units on Scale | Standard Deviation 0.1556 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 67 | 0.039 Units on Scale | Standard Deviation 0.1954 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 25 | 0.014 Units on Scale | Standard Deviation 0.1518 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 55 | 0.028 Units on Scale | Standard Deviation 0.2067 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 31 | 0.013 Units on Scale | Standard Deviation 0.1665 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Safety Follow-Up | -0.099 Units on Scale | Standard Deviation 0.1942 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | Week 37 | 0.013 Units on Scale | Standard Deviation 0.2234 |
Secondary
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks)
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.
Time frame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Population: Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signified those participants who were evaluable for the specified category at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 3/4 | 0.9 Millimeter | Standard Deviation 13.94 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 7 | -0.5 Millimeter | Standard Deviation 13.59 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 13 | -3.2 Millimeter | Standard Deviation 12.83 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 19 | -3.5 Millimeter | Standard Deviation 16.39 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 25 | -4.5 Millimeter | Standard Deviation 15.66 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 31 | -2.3 Millimeter | Standard Deviation 13.14 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 37 | -1.7 Millimeter | Standard Deviation 11.78 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 43 | -4.4 Millimeter | Standard Deviation 11.92 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 49 | -2.9 Millimeter | Standard Deviation 8.95 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 55 | -9.4 Millimeter | Standard Deviation 16.32 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 61 | -6.4 Millimeter | Standard Deviation 18.09 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 67 | -7.3 Millimeter | Standard Deviation 17.1 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | End Of Treatment | -12.2 Millimeter | Standard Deviation 22.39 |
| Chemotherapy + Best Supportive Care (BSC) | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Safety Follow-Up | -8.0 Millimeter | Standard Deviation 19.24 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 61 | 3.5 Millimeter | Standard Deviation 16.15 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 3/4 | 0.6 Millimeter | Standard Deviation 13.11 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 43 | 3.2 Millimeter | Standard Deviation 15.34 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 7 | -2.1 Millimeter | Standard Deviation 14.09 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | End Of Treatment | -10.3 Millimeter | Standard Deviation 20.84 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 13 | -0.7 Millimeter | Standard Deviation 13.41 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 49 | 2.1 Millimeter | Standard Deviation 13.04 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 19 | -0.1 Millimeter | Standard Deviation 14.93 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 67 | 4.9 Millimeter | Standard Deviation 17.31 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 25 | -1.4 Millimeter | Standard Deviation 15.76 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 55 | 3.4 Millimeter | Standard Deviation 16.52 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 31 | 1.4 Millimeter | Standard Deviation 17.61 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Safety Follow-Up | -9.6 Millimeter | Standard Deviation 20.3 |
| Avelumab | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | Week 37 | 0.9 Millimeter | Standard Deviation 20.39 |
Secondary
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values
Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented.
Time frame: From baseline up to 1276 days
Population: Safety-Maintenance Analysis (SMA) Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | lymphocyte count decreased | 0 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | neutrophil count decreased | 6 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | white blood cells decreased | 2 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | platelet count decreased | 1 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | lipase increased | 6 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | serum amylase increased | 3 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | creatinine phosphokinase increased | 0 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | creatinine increased | 0 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | creatinine increased | 1 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | lymphocyte count decreased | 1 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | lipase increased | 8 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | neutrophil count decreased | 1 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | creatinine phosphokinase increased | 2 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | white blood cells decreased | 0 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | serum amylase increased | 2 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | platelet count decreased | 0 Participants |
Secondary
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Increased in Systolic blood pressure | 57 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Decreased in Systolic blood pressure | 43 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Increased in Diastolic blood pressure | 14 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Decreased in Diastolic blood pressure | 21 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Increased in pulse rate | 46 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Decreased in pulse rate | 32 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Increased in pulse rate | 48 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Increased in Systolic blood pressure | 62 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Decreased in Diastolic blood pressure | 26 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Decreased in Systolic blood pressure | 69 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Decreased in pulse rate | 30 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Increased in Diastolic blood pressure | 24 Participants |
Secondary
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Decreased heart rate | 0 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Increased heart rate | 2 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Increased Pulse Rate interval | 1 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Increased QRS interval | 5 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcF interval greater than (>)450milisecond (ms)less than or equal to(<=)480ms | 9 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcF interval: > 480 ms <= 500 ms | 2 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcF interval: > 500 ms | 3 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcB Interval: > 450 msec <= 480 msec | 19 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcB Interval: > 480 msec <= 500 msec | 2 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcB Interval: > 500 msec | 5 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcB Interval: > 450 msec <= 480 msec | 18 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Decreased heart rate | 1 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcF interval: > 480 ms <= 500 ms | 3 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Increased heart rate | 2 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcB Interval: > 500 msec | 3 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Increased Pulse Rate interval | 3 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcF interval: > 500 ms | 1 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Increased QRS interval | 8 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcB Interval: > 480 msec <= 500 msec | 2 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | QTcF interval greater than (>)450milisecond (ms)less than or equal to(<=)480ms | 9 Participants |
Secondary
Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1
ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 | 140 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 | 144 Participants |
Secondary
Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
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 TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Any TEAEs | 214 Participants |
| Chemotherapy + Best Supportive Care (BSC) | Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Any Serious TEAE | 75 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Any TEAEs | 223 Participants |
| Avelumab | Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Any Serious TEAE | 89 Participants |
Secondary
Objective Response Rate (ORR) by Investigator Assessment
The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Objective Response Rate (ORR) by Investigator Assessment | 14.4 percentage of participants |
| Avelumab | Objective Response Rate (ORR) by Investigator Assessment | 13.3 percentage of participants |
95% CI: [0.55, 1.51]
Secondary
Progression Free Survival (PFS) by Independent Review Committee (IRC)
The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of 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.
Time frame: From randomization into maintenance phase up to 1276 days
Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Progression Free Survival (PFS) by Independent Review Committee (IRC) | 4.4 months |
| Avelumab | Progression Free Survival (PFS) by Independent Review Committee (IRC) | 3.2 months |
95% CI: [0.85, 1.28]