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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001456-21 | EudraCT Number | ||
| LOCALLY ADVANCED HEAD AND NECK | Other Identifier | Alias Study Number |
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The trial prematurely terminated as recommended by the E-DMC because the boundary for futility has been crossed.
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This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avelumab + SOC Chemoradiation Therapy | Experimental |
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| Placebo + SOC CRT | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | Avelumab + SOC Chemoradiation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator | PFS was defined as the time (in months) from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Analysis was performed using Kaplan Meier method. PD refers to any of following: 1) Locoregional PD confirmed by pathology to verify radiographic changes represent true tumor progression and not radiation effects or non-malignant contrast enhancement. 2) Locoregional clinically detectable progression confirmed by pathology. 3) Surgical removal (salvage) of primary tumor with tumor present on final pathology. 4) Salvage neck dissection greater than (>) 20 weeks after completion of CRT with tumor present on final pathology. 5) Metastatic PD. PFS data was censored on date of last adequate tumor assessment for participants with no PFS event. | From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan Meier method. | From randomization to the date of death or censored date, whichever occurred first (up to 37 months) |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Highlands Oncology Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33794205 | Derived | Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, Harrington K, Chang PM, Lin JC, Razaq MA, Teixeira MM, Lovey J, Chamois J, Rueda A, Hu C, Dunn LA, Dvorkin MV, De Beukelaer S, Pavlov D, Thurm H, Cohen E. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):450-462. doi: 10.1016/S1470-2045(20)30737-3. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Study had 3 sequential treatment phases: Lead-in, CRT, and Maintenance. There were 3 treatments administered during CRT phase: Avelumab, Cisplatin and IMRT. Reasons for discontinuation of each treatment are summarized separately. 11 participants discontinued all 3 treatments during CRT phase due to death. Two patients discontinued cisplatin due to adverse event and subsequently discontinued avelumab and IMRT due to death.
Study had 3 sequential treatment phases: Lead-in, CRT, and Maintenance. There were 3 treatments administered in parallel during CRT phase: Avelumab, Cisplatin and IMRT.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avelumab + Standard of Care Chemotherapy (SOC CRT) | Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Lead-In Phase (7 Days) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2019 | Dec 21, 2020 |
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| Chemoradiation |
| Other |
Cisplatin + Radiation Therapy |
|
| Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site | pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The pCR rate at primary site was estimated by dividing the number of participants with pCR recorded at any visit from randomization until PD per modified RECIST v1.1 or death due to any cause by the number of participants randomized who had salvage surgery at the primary site. | From randomization until PD or death (up to 37 months) |
| Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator | Locoregional failure was defined as the time from the date of randomization to the date of the first documentation of locoregional recurrence or death due to any cause per modified RECIST v1.1 as assessed by Investigator, whichever occurred first. Analysis was performed using Kaplan Meier method. | From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months) |
| Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator | Objective response (OR) was defined as a complete response (CR) or partial response (PR) per RECIST v1.1 recorded from randomization until disease progression per modified RECIST v1.1 or death due to any cause. A participant was considered to have achieved an OR if the participant had a CR or PR which did not need to be confirmed at a subsequent assessment. CR for target disease: complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis less than [<] 10 millimeter [mm]). CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<10 mm short axis) . PR: Greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target measurable lesions. The ORR was estimated by dividing the number of participants with OR (CR or PR) by the number of participants randomized. | From randomization until disease progression or death, whichever occurred first (up to 37 months) |
| Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator | Time to distant metastatic failure or distant metastasis (DM) was defined as the time from the date of randomization to the date of the first documentation of distant metastatic or death due to any cause, whichever occurred first. Distant metastatic disease was defined as new tumor identified at a site distant from the head and neck anatomic region or draining lymph nodes. Analysis was performed using Kaplan Meier method. | From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months) |
| Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator | DOR:time from first documentation of objective tumor response (CR/PR) to first documentation of PD/death due to any cause, whichever occurred first.PR:>=30% decrease under baseline of sum of diameters of all target measurable lesions. CR for target disease:complete disappearance of all target lesions with exception of nodal disease.CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. PD is any of following:1)Locoregional PD confirmed by pathology to verify radiographic changes denote true tumor progression and not radiation effects or non-malignant contrast enhancement.2)Locoregional clinically detectable progression confirmed by pathology.3)Surgical removal of primary tumor with tumor present on final pathology.4)Salvage neck dissection >20 weeks after completion of CRT with tumor present on final pathology.5)Metastatic PD. DOR data was censored on date of last adequate tumor assessment for participants with no overall response. | From the first documentation of objective tumor response to the first documentation of PD or death or censored date, whichever occurred first (up to 37 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. TEAE was defined as event with onset dates occurring during the on-treatment period. | Baseline up to 44 months |
| Number of Participants With Shift From Baseline in Clinical Laboratory Parameters | Grade 1 and 3 ranges are: Anemia:Hb:<LLN-10.0,<8.0 g/dL;LC decreased (dec):<LLN-800/mm^3,500-200/mm^3;LC increased (inc):grade 3:>20,000/mm^3:NC dec:<LLN-1500/mm^3;<1000-500/mm^3;PC dec:<LLN-75,000/mm^3;<50,000-25,000/mm^3;WBC dec:<LLN-3000/mm^3;<2000-1000/mm^3;ALT inc:>ULN-3.0*ULN;>5.0-20.0*ULN;ALP & GGT inc:>ULN-2.5*ULN;>5.0-20.0*ULN;AST inc:>ULN-3.0*ULN;>5.0-20.0*ULN;BB inc:>ULN-1.5*ULN;>3.0-10.0*ULN;CH high:>ULN-300 mg/dL;>400-500 mg/dL;CPK inc:>ULN-2.5*ULN;>5*ULN-10*ULN;Hypercalcemia:>ULN-11.5;>12.5-13.5mg/dL;Hyperglycemia:>ULN-160; >250-500mg/dL;Hyperkalemia:>ULN-5.5;>6.0-7.0mmol/L;Hypermagnesemia:>ULN-3.0;>3.0-8.0 mg/dL;Hypernatremia:>ULN-150; >155-160 mmol/L;Hypertriglyceridemia;150-300;>500-1000 mg/dL;Hypoalbuminemia:<LLN-3;<2g/dL;Hypocalcemia:<LLN-8.0;<8.0-7.0mg/dL;Hypokalemia:<LLN-3.0;<3.0-2.5mmol/L;Hypomagnesemia;<LLN-1.2;<0.9-0.7 mg/dL;Hyponatremia:<LLN-130;<130-120mmol/L; Hypophosphatemia:<LLN-2.5;<2.0-1.0mg/dL;lipase & serum amylase inc:>ULN-1.5*ULN;>2.0-5.0*ULN. | Baseline up to 15 months |
| Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure | Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured in sitting position were reported. | Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug) |
| Change From Baseline in Vital Sign - Pulse Rate | Change from baseline in pulse rate in sitting position in beats per minute was reported. | Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug) |
| Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase | EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status. | Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug) |
| Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase | EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated worse health status. In VAS participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. | Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug) |
| Change From Baseline in National Cancer Comprehensive Network Head and Neck Symptom Index-22 Item Scores (NCCN FHNSI-22) at CRT Phase and Maintenance Phase | The NCCN FHNSI-22 questionnaire measured disease symptoms, treatment side effects and overall quality of life in participants with head and neck cancer. The questionnaire contained 22 items with 5-point Likert scales ranging from 0 to 4 as follows: 'not at all = 0', a little bit = 1, somewhat = 2, quite a bit = 3 and very much = 4. Total score ranged from 0 to 88 where, higher scores represented better symptomatology, quality of life or functioning. | Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug) |
| Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) | PD-L1 biomarker expression in tumor tissue as assessed by IHC in the form of positive immune cells and tumor staining cells. | Baseline (prior to first dose) |
| Mean Percentage (%) of Total Tumor Area Occupied by Cluster of Differentiation 8 (CD8+) Cells | Description: CD8+ cells are the type of T-lymphocytes. Mean percentage of total tumor area occupied by CD8+ Cells has been reported. Area was measured in millimeter square (mm^2). | Baseline (prior to first dose) |
| Percentage of Participants With Positive and Negative Pathology of Neck Dissection | Percentage of participants with positive and negative pathology of neck dissection were reported. Positive pathology included live tumor cells present or 10% or greater vital tumor tissues. Negative pathology included no live tumor cells present, complete tumor regression, no evidence of vital tumor tissues, less than 10% vital tumor tissue, or not consistent with disease under study. | From randomization until PD as per investigator assessment (up to 37 months) |
| Maximum Plasma Concentration (Cmax) of Avelumab | Maximum observed plasma concentration (Cmax) of Avelumab is reported. | Pre-dose and end of infusion on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1 and 2 (each cycle 28 days) |
| Predose Plasma Concentration (Ctrough) of Avelumab | Ctrough refers to plasma concentration of Avelumab observed just before treatment administration. | Pre-dose on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1, 2, 5, 8, 11 (each cycle 28 days) |
| Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Total and Free Cisplastin | Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of total and free Cisplastin (in mg) administered to a participant. | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
| Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of Total and Free Cisplatin | Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast (dn) was calculated by dividing AUClast by the exact dose of cisplastin (in mg) administered to a participant. | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
| Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin | Maximum observed plasma concentration (Cmax) of total and free Cisplatin is reported. | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
| Time to Attain Maximum Observed Plasma Concentration (Tmax) of Total and Free Cisplatin | Time to reach maximum observed plasma concentration (Tmax) of total and free Cisplatin. | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
| Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point; ADA-negative participants (titer less than< cut point) and ADA ever-positive was defined as at least one positive ADA result at any time point; ADA-positive participants (titer greater than or equal to cut point) | pre-dose on Day 1 up to 30 Days after the end of treatment |
| Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status | Day 1 of lead-in phase and on Days 8 and 25 of CRT phase |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States |
| The Oncology Institute of Hope and Innovation | Anaheim | California | 92801 | United States |
| CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| Tower Hematology Oncology Medical Group | Beverly Hills | California | 90211 | United States |
| UCSD Radiation Oncology South Bay, Cancer Treatment Centers | Chula Vista | California | 91914 | United States |
| City of Hope Corona | Corona | California | 92879 | United States |
| Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc. | Corona | California | 92879 | United States |
| The Oncology Institute of Hope and Innovation | Downey | California | 90241 | United States |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte | California | 91010 | United States |
| The Oncology Institute of Hope and Innovation | Glendale | California | 91204 | United States |
| UC San Diego Medical Center- La Jolla (Thornton Hospital) | La Jolla | California | 92037 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| City of Hope Antelope Valley | Lancaster | California | 93534 | United States |
| The Oncology Institute of Hope and Innovation | Long Beach | California | 90805 | United States |
| The Oncology Institute of Hope and Innovation | Los Angeles | California | 90033 | United States |
| Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | United States |
| The Oncology Institute of Hope and Innovation | Lynwood | California | 90262 | United States |
| The Oncology Institute of Hope and Innovation | Montebello | California | 90640 | United States |
| UC Irvine Medical Center | Orange | California | 92868-3201 | United States |
| Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc. | Riverside | California | 92501 | United States |
| UC San Diego Medical Center- Hillcrest | San Diego | California | 92103 | United States |
| The Oncology Institute of Hope and Innovation | Santa Ana | California | 92705 | United States |
| City of Hope South Pasadena | South Pasadena | California | 91030 | United States |
| The Oncology Institute of Hope and Innovation | Torrance | California | 90503 | United States |
| The Oncology Institute of Hope and Innovation | West Covina | California | 91790 | United States |
| The Oncology Institute of Hope and Innovation | Whittier | California | 90602 | United States |
| Rocky Mountain Lions Eye Institute | Aurora | Colorado | 80045 | United States |
| University of Colorado Denver CTO/CTRC | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital - Anschutz Inpatient Pavilion | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital - Anschutz Outpatient Pavilion | Aurora | Colorado | 80045 | United States |
| University Of Colorado Hospital Cancer Center | Aurora | Colorado | 80045 | United States |
| Cypress Hematology & Oncology | Denver | Colorado | 80210 | United States |
| Cypress Hematology and Oncology | Parker | Colorado | 80138 | United States |
| Sylvester at Coral Gables | Coral Gables | Florida | 33146 | United States |
| Sylvester at Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Specialist Global LLC | Hialeah | Florida | 33012 | United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Hollis Cancer Center | Lakeland | Florida | 33805 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Memorial Cancer Institute at Memorial Hospital West | Pembroke Pines | Florida | 33028 | United States |
| Sylvester at Plantation | Plantation | Florida | 33324 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Primary Healthcare Associates | Flossmoor | Illinois | 60422 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Primary Healthcare Associates | Harvey | Illinois | 60426 | United States |
| Primary Healthcare Associates | Tinley Park | Illinois | 60477 | United States |
| IU Health Arnett Cancer Center | Lafayette | Indiana | 47904 | United States |
| Kansas City VA Radiation Oncology Clinic | Overland Park | Kansas | 66212 | United States |
| Ashland-Bellefonte Cancer Center | Ashland | Kentucky | 41101 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Norton Hospital | Louisville | Kentucky | 40202 | United States |
| University Medical Center, Inc. | Louisville | Kentucky | 40202 | United States |
| Norton Brownsboro Hospital | Louisville | Kentucky | 40241 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40241 | United States |
| Highlands Cancer Center | Prestonsburg | Kentucky | 41653 | United States |
| Maryland Proton Treatment Center | Baltimore | Maryland | 21201 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Karmanos Cancer Institute | Farmington Hills | Michigan | 48334 | United States |
| Herbert-Herman Cancer Center, Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Siteman Cancer Center- St. Peters | City of Saint Peters | Missouri | 63376 | United States |
| University of Missouri- Ellis Fischel Cancer Center | Columbia | Missouri | 65212 | United States |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | United States |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | United States |
| Department of Radiation Oncology Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68114 | United States |
| Memorial Sloan Kettering Cancer Center-Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center- Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Cancer Center- Bergen | Montvale | New Jersey | 07645 | United States |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | United States |
| Memorial Sloan Kettering Cancer Center Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center Westchester | Harrison | New York | 10604 | United States |
| Bellevue Hospital Center | New York | New York | 10016 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| NYU Langone Radiology | New York | New York | 10016 | United States |
| NYU Langone Radiology - Ambulatory Care Center East 41st Street | New York | New York | 10017 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10022 | United States |
| Memorial Sloan Kettering Cancer Center: Breast and Imaging Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Stony Brook University | Stony Brook | New York | 11794-7007 | United States |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | United States |
| Montefiore-Einstein Center for Cancer Care | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Memorial Sloan Kettering Cancer Center- Nassau | Uniondale | New York | 11553 | United States |
| Oncology Specialists of Charlotte, PA | Charlotte | North Carolina | 28204 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| OU Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Oklahoma Health Sciences Center- Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Lehigh Valley Health Network Cancer Center Pharmacy | Allentown | Pennsylvania | 18103 | United States |
| Lehigh Valley Health Network-Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| Radiation Oncology Cancer Services | Allentown | Pennsylvania | 18103 | United States |
| Lehigh Valley Health Network-Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Precision Cancer Research / Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| PinnacleHealth Cancer Institute | Harrisburg | Pennsylvania | 17109 | United States |
| PinnacleHealth Cancer Institute | Jacksville | Pennsylvania | 17050 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Shadyside Radiation Oncology | Pittsburgh | Pennsylvania | 15232 | United States |
| MUSC- Rutledge Tower | Charleston | South Carolina | 29403 | United States |
| Medical University of South Carolina- Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| MUSC SCTR Research Nexus Clinical Science Building | Charleston | South Carolina | 29425 | United States |
| MUSC- Ashley River Tower | Charleston | South Carolina | 29425 | United States |
| MUSC- Radiation Oncology | Charleston | South Carolina | 29425 | United States |
| MUSC- University Hospital | Charleston | South Carolina | 29425 | United States |
| GHS Cancer Institute | Easley | South Carolina | 29640 | United States |
| GHS Cancer Institute | Greenville | South Carolina | 29605 | United States |
| GHS Cancer Institute | Greenville | South Carolina | 29615 | United States |
| GHS Cancer Institute | Greer | South Carolina | 29650 | United States |
| GHS Cancer Institute | Seneca | South Carolina | 29672 | United States |
| GHS Cancer Institute | Spartanburg | South Carolina | 29307 | United States |
| The West Clinic, PC dba West Cancer Center | Germantown | Tennessee | 38138 | United States |
| The West Clinic PC dba West Cancer Center | Memphis | Tennessee | 38104 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| Texas Oncology El Paso Cancer Treatment Center | El Paso | Texas | 79902 | United States |
| William Beaumont Army Medical Center | El Paso | Texas | 79920-5001 | United States |
| William Beaumont Army Medical Center | El Paso | Texas | 79920 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Memorial Hermann Hospital - TMC | Houston | Texas | 77030 | United States |
| UTHealth/Memorial Hermann Cancer Center | Houston | Texas | 77030 | United States |
| UTMB Cancer Center at Victory Lakes | League City | Texas | 77573 | United States |
| Utah Cancer Specialists | Murray | Utah | 84157 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
| Chris O'Brien Lifehouse Medical Imaging | Camperdown | New South Wales | 2050 | Australia |
| Chris O'Brien Lifehouse Radiation Oncology Department | Camperdown | New South Wales | 2050 | Australia |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Northern Sydney Cancer Centre | St Leonards | New South Wales | 2065 | Australia |
| Illawarra Shoalhaven Local Health District | Wollongong | New South Wales | 2500 | Australia |
| Barwon Health, University Hospital Geelong | Geelong | Victoria | 3220 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Ordensklinikum Linz GmbH | Linz | A-4010 | Austria |
| University Hospital Brussels | Brussels | 1090 | Belgium |
| Grand Hopital de Charleroi - Site Notre-Dame | Charleroi | 6000 | Belgium |
| Centre Hospitalier de Jolimont | Haine-Saint-Paul | 7100 | Belgium |
| Site Sainte Elisabeth / CHU UCL Namur | Namur | 5000 | Belgium |
| GZA Hospitals Campus Sint Augustinus | Wilrijk | 2610 | Belgium |
| CHU de Quebec - Universite Laval | Québec | Quebec | G1R 2J6 | Canada |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| SUN Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Cancer Center of Guangzhou Medical University/Oncology Department | Guangzhou | Guangdong | 510095 | China |
| Affiliated Tumor Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| Hai Nan General Hospital | Haikou | Hainan | 570311 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center | Wuhan | Hubei | 430030 | China |
| Xiangya Hospital Central South University/Oncology Department | Changsha | Hunan | 410008 | China |
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | 110042 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai East Hospital/Oncology Department | Shanghai | Shanghai Municipality | 200123 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin | Angers | 49055 | France |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Hopital Pellegrin - Service de radiologie et d'imagerie | Bordeaux | 33075 | France |
| Hopital Saint-Andre | Bordeaux | 33075 | France |
| Cabinet de radiologie Privé - Dr Joseph Mocaer | Brest | 29220 | France |
| Clinique Pasteur - CFRO | Brest | 29229 | France |
| Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord | Levallois-Perret | 92309 | France |
| Institut Regional du Cancer Montpellier - Val d'Aurelle | Montpellier | 34298 | France |
| Hopital prive du Confluent S.A.S. | Nantes | 44277 | France |
| Hopital prive du Confluent S.A.S | Nantes | 44277 | France |
| Clinique Hartmann | Neuilly-sur-Seine | 92200 | France |
| Hopital Americain de Paris | Neuilly-sur-Seine | 92200 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Institut Curie | Paris | 75005 | France |
| Centre Hospitalier Prive Saint Gregoire | Saint-Grégoire | 35760 | France |
| Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau | Saint-Herblain | 44805 | France |
| Institut de cancerologie de la Loire Lucien Neuwirth | Saint-Priest-en-Jarez | 42271 | France |
| Centre Paul Strauss - Radiologie et medecine nucleaire | Strasbourg | 67065 | France |
| ICANS - Institut de cancerologie Strasbourg Europe | Strasbourg | 67200 | France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik | Berlin | BUCH | 13125 | Germany |
| Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin | Berlin | BUCH | 13125 | Germany |
| Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie | Berlin | BUCH | 13125 | Germany |
| Helios Klinikum Berlin-Buch | Berlin | BUCH | 13125 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Universitatsklinikum Jena | Jena | 07745 | Germany |
| Universitatsklinikum Jena | Jena | 07747 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93042 | Germany |
| General Oncology Hospital of Kifissia "Agioi Anargiroi" | Athens | Attica | 14564 | Greece |
| Attikon University Hospital | Haidari | Attica | 12462 | Greece |
| Euromedica General Clinic | Thessaloniki | 54645 | Greece |
| Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly | Budapest | 1122 | Hungary |
| Orszagos Onkologiai Intezet, Sugarterapias Osztaly | Budapest | 1122 | Hungary |
| Uzsoki Utcai Korhaz | Budapest | 1145 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly | Győr | 9024 | Hungary |
| Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet | Pécs | 7624 | Hungary |
| Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | 6720 | Hungary |
| St Luke's Radiation Oncology Network, St Luke's Hospital | Dublin | 6 | Ireland |
| St James's Hospital | Dublin | 8 | Ireland |
| St. James's Hospital | Dublin | 8 | Ireland |
| Blackrock Clinic | Dublin | A94 E4X7 | Ireland |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Hadassah University Hospital, Department of Oncology | Jerusalem | 91120 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| The Chaim Sheba M.C.Tel-Hashomer | Ramat Gan | 52621 | Israel |
| ASST degli Spedali Civili di Brescia | Brescia | BS | 25123 | Italy |
| Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T) | Meldola | FC | 47014 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Meldola | FC | 47014 | Italy |
| Ospedale M. Bufalini | Cesena | Forlì-cesena | 47521 | Italy |
| IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Meldola | Forlì-cesena | 47014 | Italy |
| Presidio Ospedaliero Vito Fazzi | Lecce | LE | 73100 | Italy |
| AOU Policlinico Di Modena | Modena | MO | 41124 | Italy |
| Azienda Ospedaliero-Universitaria di Parma | Parma | PR | 43126 | Italy |
| UOC Oncologia Medica, AUSL della Romagna -RAVENNA | Lugo | RA | 48022 | Italy |
| IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Ravenna | RA | 48121 | Italy |
| UOC Oncologia Medica, AUSL della Romagna - RAVENNA | Ravenna | RA | 48121 | Italy |
| AULSS 9 - Scaligera Ospedale Mater Salutis | Legnago | VR | 37045 | Italy |
| Istituto Nazionale Tumori IRCCS - Fondazione Pascale | Naples | 80131 | Italy |
| AUSL - IRCCS and Reggio Emilia | Reggio Emilia | 42123 | Italy |
| Aichi cancer center central hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Miyagi Cancer Center | Natori-shi | Miyagi | 981-1293 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | 541-8567 | Japan |
| Kindai University Hospital | Sayama | Osaka | 589-8511 | Japan |
| Saitama Cancer Center | Kita-adachi-gun | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 329-0498 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 1040045 | Japan |
| Cancer Institute Hospital, Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| Centrum Onkologii im. prof. F. Lukaszczyka | Bydgoszcz | 85-796 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii | Gliwice | 44-101 | Poland |
| SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii | Olsztyn | 10-228 | Poland |
| NZOZ Provita Prolife Centrum Medyczne | Tomaszów Mazowiecki | 97-200 | Poland |
| Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o. | Tomaszów Mazowiecki | 97-200 | Poland |
| Hospital Pedro Hispano | Matosinhos Municipality | Porto District | 4464-513 | Portugal |
| CUF Porto | Senhora da Hora | Porto District | 4460-188 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE | Vila Nova de Gaia | Porto District | 4434-502 | Portugal |
| Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E. | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio | Porto | 4099-001 | Portugal |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. | Porto | 4200-072 | Portugal |
| Centro Hospitalar São João, E.P.E | Porto | 4200-319 | Portugal |
| Julio Teixeira | Porto | 4460-188 | Portugal |
| SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine" | Chelyabinsk | 454087 | Russia |
| N. N. Blokhin NMRCO | Moscow | 115478 | Russia |
| Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary" | Omsk | 644013 | Russia |
| FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov" | Saint Petersburg | 197758 | Russia |
| SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)" | Saint Petersburg | 197758 | Russia |
| SBHI YaR "Regional Clinical Oncology Hospital" | Yaroslavl | 150054 | Russia |
| Center for Proton Therapy, National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Center for Specific Organ Cancer, National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Department of Radiation Oncology, CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun-gun | Jeollanam-do | 58128 | South Korea |
| Division of Radiation Oncology, Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Division of Radiation Oncology, Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Department of Radiation Oncology, Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Costa del Sol | Marbella | Malaga | 29603 | Spain |
| Hospital Clinico Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Institut Catala D'Oncologia de Girona | Girona | 17007 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Fundacion Instituto Valenciano de Oncologia | Valencia | 46009 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Klinik fur Radiologie und Nuklearmedizin | Basel | Canton of Basel-City | 4031 | Switzerland |
| Klinik fur Strahlentherapie und Radioonkologie | Basel | Canton of Basel-City | 4031 | Switzerland |
| Universitatsspital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
| Kantonsspital Winterthur, Medizinische Onkologie | Winterthur | Canton of Zurich | 8401 | Switzerland |
| Kantonsspital Winterthur, Radiologie | Winterthur | Canton of Zurich | 8401 | Switzerland |
| Kantonsspital Winterthur | Winterthur | Canton of Zurich | 8401 | Switzerland |
| Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Radiologia ORBV, Ospedale San Giovanni | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Institut fur Klinische Pathologie | Zurich | 8091 | Switzerland |
| Klinik fur Nuklearmedizin | Zurich | 8091 | Switzerland |
| Universitatsspital Zurich | Zurich | 8091 | Switzerland |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Chang Gung Memorial Hospital-Linkou Branch | Taoyuan City | 333 | Taiwan |
| NHS Grampian | Aberdeen | AB25 2ZN | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Bebington | CH63 4JY | United Kingdom |
| University Hospital Bristol NHS Foundation Trust | Bristol | BS2 8ED | United Kingdom |
| NHS Lothian, Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Guy's and St. Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| FG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
|
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| CRT for Avelumab or Placebo (63 Days) |
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| CRT for Cisplatin (63 Days) |
|
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| CRT for IMRT (63 Days) |
|
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| Maintenance Phase (12 Months) |
|
|
| Follow-Up Phase (90 Days) |
|
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| LT Follow-up (up to 45 Months) |
|
|
The full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Avelumab + Standard of Care Chemotherapy (SOC CRT) | Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment. |
| BG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator | PFS was defined as the time (in months) from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Analysis was performed using Kaplan Meier method. PD refers to any of following: 1) Locoregional PD confirmed by pathology to verify radiographic changes represent true tumor progression and not radiation effects or non-malignant contrast enhancement. 2) Locoregional clinically detectable progression confirmed by pathology. 3) Surgical removal (salvage) of primary tumor with tumor present on final pathology. 4) Salvage neck dissection greater than (>) 20 weeks after completion of CRT with tumor present on final pathology. 5) Metastatic PD. PFS data was censored on date of last adequate tumor assessment for participants with no PFS event. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months) |
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| Secondary | Overall Survival (OS) | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan Meier method. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of death or censored date, whichever occurred first (up to 37 months) |
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| Secondary | Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site | pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The pCR rate at primary site was estimated by dividing the number of participants with pCR recorded at any visit from randomization until PD per modified RECIST v1.1 or death due to any cause by the number of participants randomized who had salvage surgery at the primary site. | All randomized participants who had salvage surgery at the primary site. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until PD or death (up to 37 months) |
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| Secondary | Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator | Locoregional failure was defined as the time from the date of randomization to the date of the first documentation of locoregional recurrence or death due to any cause per modified RECIST v1.1 as assessed by Investigator, whichever occurred first. Analysis was performed using Kaplan Meier method. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months) |
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| Secondary | Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator | Objective response (OR) was defined as a complete response (CR) or partial response (PR) per RECIST v1.1 recorded from randomization until disease progression per modified RECIST v1.1 or death due to any cause. A participant was considered to have achieved an OR if the participant had a CR or PR which did not need to be confirmed at a subsequent assessment. CR for target disease: complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis less than [<] 10 millimeter [mm]). CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<10 mm short axis) . PR: Greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target measurable lesions. The ORR was estimated by dividing the number of participants with OR (CR or PR) by the number of participants randomized. | FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until disease progression or death, whichever occurred first (up to 37 months) |
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| Secondary | Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator | Time to distant metastatic failure or distant metastasis (DM) was defined as the time from the date of randomization to the date of the first documentation of distant metastatic or death due to any cause, whichever occurred first. Distant metastatic disease was defined as new tumor identified at a site distant from the head and neck anatomic region or draining lymph nodes. Analysis was performed using Kaplan Meier method. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months) |
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| Secondary | Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator | DOR:time from first documentation of objective tumor response (CR/PR) to first documentation of PD/death due to any cause, whichever occurred first.PR:>=30% decrease under baseline of sum of diameters of all target measurable lesions. CR for target disease:complete disappearance of all target lesions with exception of nodal disease.CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. PD is any of following:1)Locoregional PD confirmed by pathology to verify radiographic changes denote true tumor progression and not radiation effects or non-malignant contrast enhancement.2)Locoregional clinically detectable progression confirmed by pathology.3)Surgical removal of primary tumor with tumor present on final pathology.4)Salvage neck dissection >20 weeks after completion of CRT with tumor present on final pathology.5)Metastatic PD. DOR data was censored on date of last adequate tumor assessment for participants with no overall response. | Analysis population included all randomized participants who had unconfirmed CR or PR. | Posted | Median | 95% Confidence Interval | months | From the first documentation of objective tumor response to the first documentation of PD or death or censored date, whichever occurred first (up to 37 months) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. TEAE was defined as event with onset dates occurring during the on-treatment period. | Safety analysis set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 44 months |
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| Secondary | Number of Participants With Shift From Baseline in Clinical Laboratory Parameters | Grade 1 and 3 ranges are: Anemia:Hb:<LLN-10.0,<8.0 g/dL;LC decreased (dec):<LLN-800/mm^3,500-200/mm^3;LC increased (inc):grade 3:>20,000/mm^3:NC dec:<LLN-1500/mm^3;<1000-500/mm^3;PC dec:<LLN-75,000/mm^3;<50,000-25,000/mm^3;WBC dec:<LLN-3000/mm^3;<2000-1000/mm^3;ALT inc:>ULN-3.0*ULN;>5.0-20.0*ULN;ALP & GGT inc:>ULN-2.5*ULN;>5.0-20.0*ULN;AST inc:>ULN-3.0*ULN;>5.0-20.0*ULN;BB inc:>ULN-1.5*ULN;>3.0-10.0*ULN;CH high:>ULN-300 mg/dL;>400-500 mg/dL;CPK inc:>ULN-2.5*ULN;>5*ULN-10*ULN;Hypercalcemia:>ULN-11.5;>12.5-13.5mg/dL;Hyperglycemia:>ULN-160; >250-500mg/dL;Hyperkalemia:>ULN-5.5;>6.0-7.0mmol/L;Hypermagnesemia:>ULN-3.0;>3.0-8.0 mg/dL;Hypernatremia:>ULN-150; >155-160 mmol/L;Hypertriglyceridemia;150-300;>500-1000 mg/dL;Hypoalbuminemia:<LLN-3;<2g/dL;Hypocalcemia:<LLN-8.0;<8.0-7.0mg/dL;Hypokalemia:<LLN-3.0;<3.0-2.5mmol/L;Hypomagnesemia;<LLN-1.2;<0.9-0.7 mg/dL;Hyponatremia:<LLN-130;<130-120mmol/L; Hypophosphatemia:<LLN-2.5;<2.0-1.0mg/dL;lipase & serum amylase inc:>ULN-1.5*ULN;>2.0-5.0*ULN. | Safety population include all participants who received at least one dose of study drug. Here "Overall Number of Participants analyzed" signifies number of participants evaluable for this outcome measure and 'Number analyzed' signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Baseline up to 15 months |
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| Secondary | Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure | Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured in sitting position were reported. | Safety analysis set included all participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for each specified category at each specified time point. | Posted | Mean | Standard Deviation | millimeter of mercury | Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug) |
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| Secondary | Change From Baseline in Vital Sign - Pulse Rate | Change from baseline in pulse rate in sitting position in beats per minute was reported. | Safety analysis set included all participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for each specified category at each specified time point. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug) |
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| Secondary | Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase | EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status. | FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for each specified category at each specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug) |
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| Secondary | Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase | EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated worse health status. In VAS participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. | FAS included all randomized participants. FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for each specified category at each specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug) |
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| Secondary | Change From Baseline in National Cancer Comprehensive Network Head and Neck Symptom Index-22 Item Scores (NCCN FHNSI-22) at CRT Phase and Maintenance Phase | The NCCN FHNSI-22 questionnaire measured disease symptoms, treatment side effects and overall quality of life in participants with head and neck cancer. The questionnaire contained 22 items with 5-point Likert scales ranging from 0 to 4 as follows: 'not at all = 0', a little bit = 1, somewhat = 2, quite a bit = 3 and very much = 4. Total score ranged from 0 to 88 where, higher scores represented better symptomatology, quality of life or functioning. | FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for each specified category at each specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug) |
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| Secondary | Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) | PD-L1 biomarker expression in tumor tissue as assessed by IHC in the form of positive immune cells and tumor staining cells. | Biomarker analysis set was a subset of the safety analysis set included participants who had at least one screening biomarker assessment. Here' 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | % of PD-L1+ cells | Baseline (prior to first dose) |
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| Secondary | Mean Percentage (%) of Total Tumor Area Occupied by Cluster of Differentiation 8 (CD8+) Cells | Description: CD8+ cells are the type of T-lymphocytes. Mean percentage of total tumor area occupied by CD8+ Cells has been reported. Area was measured in millimeter square (mm^2). | Biomarker analysis set included all participants who had received at least one dose of study drug and who had at least one screening biomarker assessment. Here, 'Overall number of participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | % of tumor area occupied by CD8+ cells | Baseline (prior to first dose) |
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| Secondary | Percentage of Participants With Positive and Negative Pathology of Neck Dissection | Percentage of participants with positive and negative pathology of neck dissection were reported. Positive pathology included live tumor cells present or 10% or greater vital tumor tissues. Negative pathology included no live tumor cells present, complete tumor regression, no evidence of vital tumor tissues, less than 10% vital tumor tissue, or not consistent with disease under study. | Analysis population included all participants who had received at least one dose of study drug and who had salvage neck dissection. | Posted | Number | percentage of participants | From randomization until PD as per investigator assessment (up to 37 months) |
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| Secondary | Maximum Plasma Concentration (Cmax) of Avelumab | Maximum observed plasma concentration (Cmax) of Avelumab is reported. | PK concentration analysis was a subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab or cisplatin. Here' 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter | Pre-dose and end of infusion on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1 and 2 (each cycle 28 days) |
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| Secondary | Predose Plasma Concentration (Ctrough) of Avelumab | Ctrough refers to plasma concentration of Avelumab observed just before treatment administration. | PK concentration analysis was a subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the LLQ for avelumab or cisplatin. Here' 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter | Pre-dose on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1, 2, 5, 8, 11 (each cycle 28 days) |
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| Secondary | Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Total and Free Cisplastin | Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of total and free Cisplastin (in mg) administered to a participant. | PK concentration analysis was a subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the LLQ for avelumab or cisplatin. Here' 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter per milligram | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
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| Secondary | Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of Total and Free Cisplatin | Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast (dn) was calculated by dividing AUClast by the exact dose of cisplastin (in mg) administered to a participant. | PK concentration analysis was a subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the LLQ for avelumab or cisplatin. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter/milligram | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
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| Secondary | Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin | Maximum observed plasma concentration (Cmax) of total and free Cisplatin is reported. | PK concentration analysis was a subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the LLQ for avelumab or cisplatin. Here' 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
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| Secondary | Time to Attain Maximum Observed Plasma Concentration (Tmax) of Total and Free Cisplatin | Time to reach maximum observed plasma concentration (Tmax) of total and free Cisplatin. | PK concentration analysis was a subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab or cisplatin. Here' 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | hour | Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point; ADA-negative participants (titer less than< cut point) and ADA ever-positive was defined as at least one positive ADA result at any time point; ADA-positive participants (titer greater than or equal to cut point) | Immunogenicity analysis set was a subset of the safety analysis set which included participants who had at least 1 ADA/nAb sample collected for avelumab in Avelumab + Standard of Care Chemotherapy (SOC CRT) arm. | Posted | Count of Participants | Participants | pre-dose on Day 1 up to 30 Days after the end of treatment |
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| Secondary | Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status | Since the study was terminated, sponsor decided not to collect data for nAb, hence not reported. | Posted | Day 1 of lead-in phase and on Days 8 and 25 of CRT phase |
|
Baseline up to 44 months
Same event may appear as AE, serious AE, here distinct events are presented. Event may be serious in 1 participant and non-serious in another or 1 participant may have experienced both serious, non-serious event. Safety analysis set evaluated. Discontinuation during CRT phase due to death is the discontinuation reason for treatments received at the time of event in the treatment disposition summary.All deaths reported as reason of discontinuation at any phase are included in all-cause mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avelumab + Standard of Care Chemotherapy (SOC CRT) | Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment. | 86 | 348 | 184 | 348 | 344 | 348 |
| EG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. | 62 | 344 | 177 | 344 | 340 | 344 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Splenic haematoma | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pterygium | Eye disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Mouth swelling | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Swelling | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Endocarditis candida | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stoma site abscess | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gastrostomy failure | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pancreatic injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Radiation associated pain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Radiation fibrosis | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Radiation injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stoma site inflammation | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stoma site pain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Eastern Cooperative Oncology Group performance status worsened | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oligoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oesophageal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Transitional cell cancer of the renal pelvis and ureter | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Brain hypoxia | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Subacute combined cord degeneration | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Embedded device | Product Issues | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Laryngeal necrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngeal necrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Respiratory tract oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gastrostomy | Surgical and medical procedures | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Phlebitis superficial | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vascular rupture | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Venous haemorrhage | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Osteoradionecrosis | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2019 | Dec 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
Not provided
Not provided
| Physician Decision |
|
| Global Deterioration of Health Status |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| Physician Decision |
|
| Global Deterioration of Health Status |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| Global Deterioration of Health Status |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| Adverse Event |
|
| Non-compliance With Study Drug |
|
| Physician Decision |
|
| Global Deterioration of Health Status |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| Study Terminated by Sponsor |
|
| Lost to Follow-up |
|
| Other |
|
| Study Terminated by Sponsor |
|
| Lost to Follow-up |
|
| Study Terminated by Sponsor |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 |
| Placebo + SOC CRT |
Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| Placebo + SOC CRT |
Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
|
|
| OG001 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. |
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