Retrospective Case Series Experience
The most common adverse reactions (occurring in ≥ 13% of patients), regardless of causality, are: Infections, vomiting, abdominal pain, pyrexia, tonsilitis, anemia, ear infection, diarrhea, nasopharyngitis, and headache.
Table 1 summarizes adverse reactions occurring in 2 or more patients treated with Carbaglu in the retrospective case series. Because these reactions were reported retrospectively, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Table 1: Adverse Reactions Reported in ≥ 2 Patients in the Retrospective Case Series treated with Carbaglu
|System Organ Class Preferred Term||Number of Patients
|Blood and lymphatic system disorders|
|Ear and labyrinth disorders|
|Ear infection||3 (13)|
|Abdominal pain||4 (17)|
|General disorders and administration site conditions|
|Infections and infestations|
|Hemoglobin decreased||3 (13)|
|Weight decreased||2 (9)|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|Skin and subcutaneous tissue disorders|