CLL-11 Stage II safety information
CLL-11 Stage II: Summary of investigator-reported adverse reactions 1
- Withdrawals from treatment due to adverse reactions: 13% of patients receiving GAZYVA + Clb vs 8% of patients receiving rituximab product + Clb 7
Protocol modifications were implemented to help mitigate infusion reactions. For more information, click here.
CLL-11 Stage II: Summary of laboratory abnormalities 1
Increased monitoring is recommended in the first cycle of GAZYVA 1
- An increased rate of thrombocytopenia was observed in Cycle 1,
which decreased with subsequent cycles
- The overall incidence of hemorrhagic events was similar in the GAZYVA and rituximab product treated arms, with 4 and 3 fatal events reported, respectively
The rate of infections was similar between the GAZYVA and rituximab product treated arms 1
- The infection rates in the GAZYVA and rituximab product
treated arms were comparable (38% vs 37%)
- Grades 3-4: 11% vs 13%, respectively
- Fatal events: 1% of patients in each of the treatment arms
Select CLL-11 Stage II safety information
Adverse reactions for GAZYVA + chlorambucil vs rituximab product + chlorambucil
Infusion-Related Reactions: The incidence of infusion reactions was 65% with the first infusion of GAZYVA. The incidence of Grade 3 or 4 infusion reactions was 20% with 7% of patients discontinuing therapy. The incidence of reactions with subsequent infusions was 3% with the second 1,000 mg and <1% thereafter. No Grade 3 or 4 infusion reactions were reported beyond the first 1,000 mg infused.
Neutropenia: The incidence of neutropenia reported as an adverse reaction was 38% in the GAZYVA treated arm and 32% in the rituximab product treated arm, with the incidence of serious adverse events being 1% and <1%, respectively. Cases of late-onset neutropenia (occurring 28 days after completion of treatment or later) were 16% in the GAZYVA treated arm and 12% in the rituximab product treated arm.
Infections: The incidence of infections was similar between GAZYVA and rituximab product treated arms. Thirty-eight percent of patients in the GAZYVA treated arm and 37% in the rituximab product treated arm experienced an infection, with Grade 3 to 4 rates being 11% and 13%, respectively. Fatal events were reported in 1% of patients in both arms.
Thrombocytopenia: The overall incidence of thrombocytopenia reported as an adverse reaction was 14% in the GAZYVA treated arm and 7% in the rituximab product treated arm, with the incidence of Grade 3 to 4 events being 10% and 3%, respectively. Four percent of patients in the GAZYVA treated arm experienced acute thrombocytopenia (occurring within 24 hours after the GAZYVA infusion). The overall incidence of hemorrhagic events and the number of fatal hemorrhagic events were similar between the treatment arms, with 3 in the rituximab product arm and 4 in the GAZYVA treated arm. However, all fatal hemorrhagic events in patients treated with GAZYVA occurred in Cycle 1.
Tumor Lysis Syndrome: The incidence of Grade 3 or 4 tumor lysis syndrome was 2% in the GAZYVA treated arm.
Musculoskeletal Disorders: Adverse reactions related to musculoskeletal disorders, including pain, have been reported in the GAZYVA treated arm with higher incidence than in the rituximab product treated arm (18% vs 15%).
Liver Enzyme Elevations: Hepatic enzyme elevations occurred in patients who received GAZYVA in clinical trials and had normal baseline hepatic enzyme levels (AST, ALT, and ALP). The events occurred most frequently within 24-48 hours of the first infusion. There was no clinically meaningful difference in overall hepatotoxicity adverse reactions between all arms (4% of patients in the GAZYVA treated arm).
Gastrointestinal Perforation: Cases of gastrointestinal perforation have been reported in patients receiving GAZYVA.
Worsening of Pre-existing Cardiac Conditions: Fatal cardiac events have been reported in patients treated with GAZYVA.