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Table 3 Adverse events

From: Azithromycin in severe malaria bacterial co-infection in African children (TABS-PKPD): a phase II randomised controlled trial

 

10 mg/kg

15 mg/kg

15 vs 10 p value

20 mg/kg

20 vs 10 p value

Control group

SAEs

 Number of children ever having an SAE

3 (9%)

3 (9%)

1.00

4 (11%)

1.00

2 (4%)

 Number of SAEs

3

3

 

4

 

2

SAE criteria

 Fatal

1 (33%)

1 (33%)

 

1 (25%)

 

0 (0%)

 Life-threatening

0 (0%)

0 (0%)

 

0 (0%)

 

0 (0%)

 Caused or prolonged hospitalisation

2 (67%)

2 (67%)

 

3 (75%)

 

2 (100%)

 Persistent or significant disability/incapacity

0 (0%)

0 (0%)

 

0 (0%)

 

0 (0%)

 Other important medical condition

0 (0%)

0 (0%)

 

0 (0%)

 

0 (0%)

  1. No further grade 3/4 AEs were reported that were not SAEs. No SAEs were judged to be related to azithromycin, the dose of azithromycin, or lead to a change in azithromycin