NCT02603432 · OUTCOME

Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3 (G3), Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) · Source last updated 2024-03-27

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: For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)

What was measured

Hematology (Anemia G3: hemoglobin\<8.0 grams per deciliter \[g/dL\],\<4.9 millimoles (mmol)/liter (L),\<80 g/L, transfusion indicated, Grade 4 \[G4\]: life-threatening consequences, urgent intervention indicated, Grade 5 \[G5\]: death; platelet count decreased-G3:\<50.0 to 25.0\*10\^9/L, G4: \<25.0\*10\^9/L; lymphocyte count decreased-G3:\<0.5-0.2\*10\^9/L, G4:\<0.2\*10\^9/L; neutrophil count decreased-G3:\<1.0 to 0.5\*10\^9 /L, G4:\<0.5\*10\^9/L). Chemistry (creatinine increased-G3:\>3.0 to 6.0\*upper limit of normal \[ULN\], G4:\>6.0\*ULN; serum amylase increased, lipase increased-G3:\>2.0- 5.0\*ULN, G4:\>5.0\*ULN. Aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]-G3:\>5.0 to 20.0\*ULN, G4:\>20.0\*ULN\]. Blood bilirubin increased-\[G3:\>3.0 to 10.0\*ULN, G4:\>10.0\*ULN\], Creatine phosphokinase \[CPK\] increased- \[G3:\>5.0 to 10.0\*ULN, G4:\>10.0\*ULN\], Hyperglycemia-\[G3:\>250 to 500 mg/dL; \>13.9 to 27.8 mmol/L hospitalization indicated, G4:\>500 mg/DL; \>27.8 mmol/L life-threatening consequences\]).

Analysis population: Safety analysis set included all participants who had received at least one dose of study drug on arm 'Avelumab+BSC' or completed C1D1 on arm 'BSC'. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number analyzed (n)' = Participants evaluable for this outcome measure for each specified row.

Groups in this outcome

Avelumab + Best Supportive Care (BSC)

Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.

Best Supportive Care

As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.

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