Table 2

 Adverse events (AEs) recorded during the study in NHV and patients with SLE (subjects without any AE are not shown)

Adverse event*IntensityRelation to ETI-104Action taken
*AEs lasted for up to 7 days, the six AEs considered as being possibly related to the drug administration lasted for up to 24 hours with a mean time period of 8 hours (range 2–24); †all subjects received 5 mg ETI-104 except NHV 2 who received 1 mg ETI-104; ‡AE was recorded within 24 hours after dosing, the rest days later; §fulfils criteria of a serious AE, but the meniscus lesion was diagnosed before entering the study.
NHV No
2†Headache‡MildUnrelatedNone
6Haematoma at IV line‡MildUnrelatedNone
Skin reaction to tape dressing at IV line‡MildPossibly relatedNone
7Headache‡MildUnrelatedNone
Headache‡ModerateUnrelated500 mg Acetomephenone
HeadacheMildUnrelatedNone
Skin reaction to tape dressing at IV line‡MildPossibly relatedNone
8Skin reaction to tape dressing at IV line‡MildPossibly relatedNone
101HeadacheMildUnrelated500 mg Acetomephenone
HeadacheMildUnrelated1000 mg Acetomephenone
Patient No
2Skin reaction to tape dressing at IV line‡MildPossibly relatedNone
Mild cold, sore throat, and rhinitisMildUnrelatedNone
Diarrhoea, vomitingModerateUnrelated2 mg Loperamide
4HeadacheMildUnrelated2000 mg Aspirin
Meniscus lesion left kneeModerateUnrelatedSurgery§
HeadacheModerateUnrelated500 mg Aspirin
5Skin reaction to tape dressing at IV line‡MildPossibly relatedNone
6Skin reaction to tape dressing at IV line‡MildPossibly relatedNone
Increasing arthralgia, with reduction of steroidsMildUnrelatedNone
DiarrhoeaMildUnrelatedNone
HeadacheMildUnrelated500 mg Aspirin