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Table 2 (abstract P076). Summary of adverse events (AE) upto last follow up visit (LFU) in REPROVE and RECLAIM studies

From: 39th International Symposium on Intensive Care and Emergency Medicine

 

INDIAN POPULATION

OVERALL POPULATION

REPROVE study

 n (%)

CAZ-AVI (n=36)

MER (n=42)

CAZ-AVI (N=529)

MER (N=529)

 Any AE

23 (63.9)

33(78.6)

302 (74.6)

299 (74.2)

 Any AE leading to death

0

0

26(6.4)

23 (5.7)

 Any serious AE

0

0

75(18.5)

54(13.4)

 Any AE leading to discontinuation

0

0

16(4.0)

11(2.7)

 Any AE of severe intensity

0

0

66 (16.3)

51 (12.7)

RECLAIM study

 n (%)

CAZ-AVI + MTZ (n=62)

MER (n=63)

CAZ-AVI + MTZ

(N=529)

MER (N=529)

 Any AE

44 (71.0)

35(55.6)

243 (45.9)

227 (42.9)

 Any AE leading to death

1(1.6)

0

8 (1.5)

5 (0.9)

 Any serious AE

1(1.6)

1(1.6)

42(7.9)

40(7.6)

 Any AE leading to discontinuation

1(1.6)

2(3.2)

14(2.6)

191.6)

 Any AE of severe intensity

1(1.6)

1(1.6)

30 (5.7)

36 (6.8)