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NCT01772004 · OUTCOME

Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) · Source last updated 2021-12-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to Day 2511

What was measured

AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.

Analysis population: SAF included all participants who have received at least 1 dose of study treatment.

Groups in this outcome

Dose Escalation Cohort: Avelumab 1.0 mg/kg

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.

Dose Escalation Cohort: Avelumab 3.0 mg/kg

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Dose Escalation Cohort: Avelumab 10.0 mg/kg

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Dose Escalation Cohort: Avelumab 20.0 mg/kg

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly

Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: NSCLC, Post-platinum Doublet

Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: NSCLC, First Line

Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: Metastatic Breast Cancer

Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: GC/GEJC Progressed

Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: GC/GEJC Non Progressed

Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Colorectal Cancer

Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Castrate-resistant Prostate Cancer

Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Adrenocortical Carcinoma

Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Melanoma

Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Mesothelioma

Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Urothelial Carcinoma

Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Ovarian Cancer

Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)

Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)

Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: Ovarian Cancer

Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: Urothelial Carcinoma

Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: GC/GEJC, Third Line

Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: HNSCC

Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort: Avelumab 1.0 mg/kg4
Dose Escalation Cohort: Avelumab 3.0 mg/kg13
Dose Escalation Cohort: Avelumab 10.0 mg/kg15
Dose Escalation Cohort: Avelumab 20.0 mg/kg21
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly8
Primary Expansion Cohort: NSCLC, Post-platinum Doublet184
Primary Expansion Cohort: NSCLC, First Line156
Primary Expansion Cohort: Metastatic Breast Cancer168
Primary Expansion Cohort: GC/GEJC Progressed60
Primary Expansion Cohort: GC/GEJC Non Progressed90
Secondary Expansion Cohort: Colorectal Cancer21
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer18
Secondary Expansion Cohort: Adrenocortical Carcinoma50
Secondary Expansion Cohort: Melanoma51
Secondary Expansion Cohort: Mesothelioma53
Secondary Expansion Cohort: Urothelial Carcinoma44
Secondary Expansion Cohort: Ovarian Cancer125
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)62
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)20
Efficacy Expansion Cohort: Ovarian Cancer103
Efficacy Expansion Cohort: Urothelial Carcinoma205
Efficacy Expansion Cohort: GC/GEJC, Third Line132
Efficacy Expansion Cohort: HNSCC153

Reported measurements

Participants with Treatment-Related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Avelumab 1.0 mg/kg3Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg9Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg14Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg17Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly7Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, Post-platinum Doublet146Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line109Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer118Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed28Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed57Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer16Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer15Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma41Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma39Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma43Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma32Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer86Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)51Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)14Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer65Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma144Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line71Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC83Not reportedNot reportedNot reportedNot reported
Participants with Treatment-Related TEAEs with Grade 1 severity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Avelumab 1.0 mg/kg1Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg5Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg7Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg6Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly2Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, Post-platinum Doublet46Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line29Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer52Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed14Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed27Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer4Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer8Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma12Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma15Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma8Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma11Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer46Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)20Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)4Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer30Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma50Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line25Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC39Not reportedNot reportedNot reportedNot reported
Participants with Treatment-Related TEAEs with Grade 2 severity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Avelumab 1.0 mg/kg1Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg4Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg3Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg8Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly4Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, Post-platinum Doublet71Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line60Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer46Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed9Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed22Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer9Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer6Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma21Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma20Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma30Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma18Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer31Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)23Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)9Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer26Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma70Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line33Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC34Not reportedNot reportedNot reportedNot reported
Participants with Treatment-Related TEAEs with Grade 3 severity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Avelumab 1.0 mg/kg1Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg3Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg2Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly1Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, Post-platinum Doublet21Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line17Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer13Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed4Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed7Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer3Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer1Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma8Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma4Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma3Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma2Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer7Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)3Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)1Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer8Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma20Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line11Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC9Not reportedNot reportedNot reportedNot reported
Participants with Treatment-Related TEAEs with Grade 4 severity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Avelumab 1.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg1Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg1Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, Post-platinum Doublet8Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line3Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer5Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed1Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma2Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma1Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer2Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)5Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)0Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer1Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma3Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line1Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC1Not reportedNot reportedNot reportedNot reported
Participants with Treatment-Related TEAEs with Grade 5 severity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Avelumab 1.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, Post-platinum Doublet0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer2Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed1Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)0Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer0Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma1Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line1Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC0Not reportedNot reportedNot reportedNot reported
Participants with Treatment-Related TEAEs with missing Grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort: Avelumab 1.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 3.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 20.0 mg/kg0Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, Post-platinum Doublet0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed0Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)0Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer0Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma0Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line0Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        17
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        146
      7. group Id
        OG006
        value
        109
      8. group Id
        OG007
        value
        118
      9. group Id
        OG008
        value
        28
      10. group Id
        OG009
        value
        57
      11. group Id
        OG010
        value
        16
      12. group Id
        OG011
        value
        15
    title
    Participants with Treatment-Related TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        46
      7. group Id
        OG006
        value
        29
      8. group Id
        OG007
        value
        52
      9. group Id
        OG008
        value
        14
      10. group Id
        OG009
        value
        27
      11. group Id
        OG010
        value
        4
      12. group Id
        OG011
        value
        8
    title
    Participants with Treatment-Related TEAEs with Grade 1 severity
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        71
      7. group Id
        OG006
        value
        60
      8. group Id
        OG007
        value
        46
      9. group Id
        OG008
        value
        9
      10. group Id
        OG009
        value
        22
      11. group Id
        OG010
        value
        9
      12. group Id
        OG011
        value
        6
    title
    Participants with Treatment-Related TEAEs with Grade 2 severity
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        21
      7. group Id
        OG006
        value
        17
      8. group Id
        OG007
        value
        13
      9. group Id
        OG008
        value
        4
      10. group Id
        OG009
        value
        7
      11. group Id
        OG010
        value
        3
      12. group Id
        OG011
        value
        1
    title
    Participants with Treatment-Related TEAEs with Grade 3 severity
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Participants with Treatment-Related TEAEs with Grade 4 severity
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Participants with Treatment-Related TEAEs with Grade 5 severity
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Participants with Treatment-Related TEAEs with missing Grade
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      184
    7. group Id
      OG006
      value
      156
    8. group Id
      OG007
      value
      168
    9. group Id
      OG008
      value
      60
    10. group Id
      OG009
      value
      90
    11. group Id
      OG010
      value
      21
    12. group Id
      OG011
      value
      18
    units
    Participants
description
AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
groups
  1. description
    Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
    id
    OG000
    title
    Dose Escalation Cohort: Avelumab 1.0 mg/kg
  2. description
    Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG001
    title
    Dose Escalation Cohort: Avelumab 3.0 mg/kg
  3. description
    Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG002
    title
    Dose Escalation Cohort: Avelumab 10.0 mg/kg
  4. description
    Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG003
    title
    Dose Escalation Cohort: Avelumab 20.0 mg/kg
  5. description
    Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG004
    title
    Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
  6. description
    Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG005
    title
    Primary Expansion Cohort: NSCLC, Post-platinum Doublet
  7. description
    Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG006
    title
    Primary Expansion Cohort: NSCLC, First Line
  8. description
    Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG007
    title
    Primary Expansion Cohort: Metastatic Breast Cancer
  9. description
    Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG008
    title
    Primary Expansion Cohort: GC/GEJC Progressed
  10. description
    Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG009
    title
    Primary Expansion Cohort: GC/GEJC Non Progressed
  11. description
    Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG010
    title
    Secondary Expansion Cohort: Colorectal Cancer
  12. description
    Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG011
    title
    Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
param Type
COUNT_OF_PARTICIPANTS
population Description
SAF included all participants who have received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Baseline up to Day 2511
title
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
type
SECONDARY
unit Of Measure
Participants

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