Time to onset of symptoms from leukapheresis or infusion | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Case No. | Age (years) | Serious report? b | Preferred Termc | Rash | Clinical description | Day No. | Leukapheresis No. | Infusion No. | Medical historyd | Concomitant medications |
Reports describing events in temporal association with sipuleucel-T | ||||||||||
1e | 70 | Yes | Pruritus generalized | No | Itching on palms, head, torso, and soles of feet | 10 | ~ | 2 | Hypertension, diabetes | Cetirizine, cyproheptadine, doxepin, dutasteride, famotidine, flecainide, magnesium oxide, metformin, mometasone (inhaled), montelukast, olmesartan, prednisone |
2 | 69 | No | Pruritus | Yes | Broke out in a rash, itching | 2 | ~ | 2 | NOS | Enzalutamide, metformin, tocopherol-fish oil |
3 | 61 | No | Pruritus | Yes | Tingling and discomfort in hands, then forearm rash (looked like red rings) with facial swelling; severe itching; eyelid swelling. Ten days after infusion was well except for itching | 7 | ~ | 3 | NOS | Aspirin, calcium, famotidine, lisinopril, vitamin D |
4 | 81 | Yes | Pruritus | Yes | Rash, itching, rigors, nausea, chest tightness, hypotension, vomited and hypoxic (85%) after 75–80% of infusion administered. Infusion discontinued. Admitted to hospital due to lack of response to medical therapy | 0 | ~ | 1 | Hypertension, hypercholesterolemia | Atenolol, calcium/cholecalciferol, citalopram, enalapril, simvastatin, vitamins |
5 | 73 | Yes | Pruritus | Yes | Swelling right upper arm (superficial thrombophlebitis), rash (IV catheter right hand), itching, tingling, cough, dyspnea | 0 | ~ | 2 | Deep vein thrombosis | NOS |
Reports describing events in temporal association with leukapheresis (preceding sipuleucel-T) | ||||||||||
6 | 82 | No | Injection site pruritus | No | Right arm injection site itching | 1 | 1 | ~ | Cardiac disorder, diabetes | Atenolol, furosemide, levothyroxine |
7 | 63 | No | Eye pruritus | No | Two separate events of allergic reaction with watery and itchy eyes associated with leukapheresis (tolerated three infusions without problem) | 0 | 1 and 3 | ~ | NOS | NOS |
Report with insufficient information to assess temporal relationship with sipuleucel-T | ||||||||||
8 | 87 | No | Catheter site pruritus | No | Catheter site pruritus; device related infection | NOS | NOS | NOS | NOS | Aspirin, calcium carbonate, denosumab, fiber, finasteride, hydrochlorothiazide/lisinopril, probiotic |