Adverse Reactions for SARCLISA + Pd
Adverse reactions (≥10%) in patients receiving SARCLISA + Pd with a difference between arms of ≥5% compared with control arm1
aPneumonia includes atypical pneumonia, bronchopulmonary aspergillosis, pneumonia, pneumonia haemophilus, pneumonia influenzal, pneumonia pneumococcal, pneumonia streptococcal, pneumonia viral, candida pneumonia, pneumonia bacterial, haemophilus infection, lung infection, pneumonia fungal, and Pneumocystis jirovecii pneumonia.
bUpper respiratory tract infection includes bronchiolitis, bronchitis, bronchitis viral, chronic sinusitis, fungal pharyngitis, influenza-like illness, laryngitis, nasopharyngitis, parainfluenzae virus infection, pharyngitis, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tracheitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.
cDyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest.
Serious and fatal adverse reactions1
- Serious adverse reactions occurred in 62% of patients receiving SARCLISA + Pd
- Serious adverse reactions in >5% of patients who received SARCLISA + Pd included pneumonia (26%), upper respiratory tract infection (7%), and febrile neutropenia (7%)
- Fatal adverse reactions occurred in 11% of patients (those that occurred in more than 1% of patients were pneumonia and other infections [3%])
Treatment-emergent hematology laboratory abnormalities
in patients receiving SARCLISA + Pd vs Pd alone1
Treatment-emergent hematology laboratory abnormalities in patients receiving SARCLISA + Pd vs Pd alone1
- Dosage interruptions due to an adverse reaction occurred in 31% of patients who received SARCLISA + Pd. The most frequent adverse reaction requiring dosage interruption was IRR (28%)
- 7% of patients receiving SARCLISA + Pd permanently discontinued treatment due to adverse reactions
- Discontinuations from treatment due to infection were reported in 2.6% of patients receiving SARCLISA + Pd vs 5.4% of patients receiving Pd alone
- SARCLISA alone was discontinued in 3% of patients due to IRRs
IRRs in patients receiving SARCLISA + Pd1,2