Real-world safety of ulinastatin: a post-marketing surveillance of 11,252 patients in China

Table 4 Occurrence and outcome of ulinastatin ADR/ADE

No.	ICU or General	Gender	Age	Events	Severity*	Treatment	Further treatment	Outcome	Duration of outcome	Relevance
1	General	Female	66	Liver function damage	1	None	None	Improved	5d	Possibly
2	General	Male	58	Thrombocytosis	1	Discontinuation	None	Recovered	11d	Possibly
3	ICU	Female	42	Abnormal liver function	1	Discontinuation	None	Recovered	4d	Possibly
4	ICU	Female	57	Thrombocytopenia	1	Discontinuation	None	Recovered	5d	Possibly
5	ICU	Male	36	Abnormal liver function	1	Discontinuation	None	Recovered	2d	Possibly
6	ICU	Male	53	Rash	1	None	Local use of calamine lotion	Recovered	8d	Possibly
7	ICU	Male	53	Thrombocytosis	4	Discontinuation	None	Improved	10d	Possibly
8	ICU	Male	57	Abnormal liver function	2	Discontinuation	None	Recovered	7d	Probably
9	ICU	Male	58	Leukocytosis	1	None	None	Recovered	1d	Possibly
10	ICU	Male	58	Leukopenia	1	Discontinuation	None	Improved	1d	Possibly
11	ICU	Male	76	Abnormal liver function	4	Discontinuation	None	Improved	1d	Possibly

* The severity grades of adverse events in the Common Adverse Event Evaluation Standard 4.0 (CTCAE) (1, 2, 3, 4)