Table 3 Long-term adverse events in 124 infusions
Events | Number of events (%) | |||||
|---|---|---|---|---|---|---|
Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
Infection (N = 35 events) | ||||||
Bacteria | 14 (11.3) | 1 (0.8) | 2 (1.6) | 8 (6) | 1 (0.8) | 2 (1.6) |
Pseudomonas spp. septicemia | 4 (3.2) | 0 (0.0) | 0 (0.0) | 2 (1.6) | 1 (0.8) | 1 (0.8) |
E.coli septicemia | 3 (2.4) | 0 (0.0) | 0 (0.0) | 2 (1.6) | 0 (0.0) | 1 (0.8) |
Bacterial infection/diarrhea | 4 (3.2) | 1 (0.8) | 2 (1.6) | 1 (0.8) | 0 (0.0) | 0 (0.0) |
Acute bacterial cholangitis | 2 (1.6) | 0 (0.0) | 0 (0.0) | 2 (1.6) | 0 (0.0) | 0 (0.0) |
Gram negative septicemia | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1 (0.8) | 0 (0.0) | 0 (0.0) |
Virus | 15 (12.1) | 13 (10.5) | 0 (0.0) | 2 (1.6) | 0 (0.0) | 0 (0.0) |
URI | 10 (8.1) | 10 (8.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Viral gastroenteritis | 1 (0.8) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Varicella | 1 (0.8) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Herpes viral infection | 1 (0.8) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
CMV infection | 2 (1.6) | 0 (0.0) | 0 (0.0) | 2 (1.6) | 0 (0.0) | 0 (0.0) |
Fungus | 6 (4.8) | 0 (0.0) | 1 (0.8) | 3 (2.4) | 2 (1.6) | 0 (0.0) |
Pneumonia | 3 (2.4) | 0 (0.0) | 0 (0.0) | 3 (2.4) | 0 (0.0) | 0 (0.0) |
IPA with LUL aneurysm rupture | 2 (1.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (1.6) | 0 (0.0) |
Cutaneous candidiasis | 1 (0.8) | 0 (0.0) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Mycobacteria | 2 (1.6) | 0 (0.0) | 0 (0.0) | 2 (1.6) | 0 (0.0) | 0 (0.0) |
Hematologic (N = 33 events) | ||||||
Anemia | 5 (4.0) | 2 (1.6) | 2 (1.6) | 1 (0.8) | 0 (0.0) | 0 (0.0) |
Neutropenia | 10 (8.1) | 0 (0.0) | 6 (4.8) | 4 (3.2) | 0 (0.0) | 0 (0.0) |
Lymphopenia | 15 (12.1) | 8 (6.5) | 7 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Thrombocytopenia | 3 (2.4) | 1 (0.8) | 1 (0.8) | 1 (0.8) | 0 (0.0) | 0 (0.0) |
Chylous ascites (N = 1 event) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1 (0.8) | 0 (0.0) | 0 (0.0) |
Others (N = 10 events) | ||||||
Transaminitis | 6 (4.8) | 6 (4.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Respiratory failure | 1 (0.8) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Muscle pain | 1 (0.8) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Fatigue | 1 (0.8) | 0 (0.0) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Nausea/Vomiting | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1 (0.8) | 0 (0.0) | 0 (0.0) |