|
Number of casesa
|
Incidence rate (95% CI)b
|
---|
Mild-to-moderate adverse drug reactions
|
11
|
30.7 (15.3–55.0)
|
Anemia
|
1
|
2.8 (0.1–15.6)
|
Thrombocytopenia
|
2
|
5.6 (0.7–20.2)
|
LFT abnormality
|
3
|
8.4 (1.7–24.5)
|
Skin rash
|
2
|
5.6 (0.7–20.2)
|
Azotemia
|
1
|
2.8 (0.1–15.6)
|
Othersc
|
2
|
5.6 (0.7–20.2)
|
Serious adverse drug reactionsd
|
1
|
2.8 (0.1–15.6)
|
Pancytopeniad
|
1
|
2.8 (0.1–15.6)
|
Stevens–Johnson syndrome
|
0
|
NA
|
- CI confidence interval, LFT liver function test, NA non-applicable
- aTotal observation period was 31.0 person-years for 45 episodes
- bRate per 100 person-years
- cIncluding headache (n = 1) and tingling sensation (n = 1)
- dOccurred in the non-high-risk subgroup