Table 2 Summary of observed adverse drug reactions.
Cohort 1 (n = 3)Cohort 2 (n = 3)Cohort 3 (n = 4)Total (n = 10)
PatientsEventsPatientsEventsPatientsEventsPatientsEvents
All adverse drug reactions324323 (1)425 (3)1072 (4)
Blood and lymphatic
system disorders
12333378
Anemia12333378
Skin and subcutaneous
tissue disorders
000011 (1)11 (1)
Eczema000011 (1)11 (1)
Renal and urinary disorders11000011
Hematuria11000011
Laboratory and physical
examination
321320 (1)421 (2)1062 (3)
Albuminuria22223377
β-2-Microglobulin increased00002222
N-acetyl-β-d-glucosaminidase
increased
353433912
Blood fibrinogen decreased00110011
Blood fibrinogen increased11000011
Blood glucose increased00001111
Diastolic pressure increased00230023
C-reactive protein increased11000011
Complement component
C3 increased
22000022
Urinary blood present11000011
Oxygen saturation decreased00001111
Respiratory rate increased00001111
White blood cell count increased11000011
Ejection fraction decreased0011 (1)0011 (1)
Proteinuria*123648 (2)816 (2)
Brain natriuretic peptide increased11110022
Urine protein/creatinine
ratio increased
11000011
Urine ketone body present11000011
Cystatin C increased00110011
Tumor necrosis factor-α increased11000011
Interleukin level increased22112255

Values in parentheses include events classified as a grade 2 adverse drug reaction.

*Results of the pyrogallol red method. Remeasurement using the Coomassie brilliant blue method showed no proteinuria.