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. Author manuscript; available in PMC: 2018 Nov 9.
Published in final edited form as: N Engl J Med. 2018 Nov 9;379(19):1801–1810. doi: 10.1056/NEJMoa1706854

Table 2.

Adverse Events (AEs) Following Treatment for Lymphatic Filariasis

DEC/ALB (N=91) IVM/DEC/ALB (N=41)
Number of participants with AEs (percent)
At least one AE 37 (41) 24 (59)
Individuals with two or more AEs 24 (26) 19 (46)*
Fever§ 19 (21) 14 (34)
Hemodynamic changes 4 (4) 5 (12)
Overall Grade 1 AEs (subjective) 36 (40) 22 (54)
Overall Grade 2 and 3 AEs with severity grade >1 5 (5) 11 (27)***
Frequency of AEs with severity grade >1
   Fatigue 5 (5) 8 (20)
   Headache 3 (3) 7 (17)
   Nausea/vomiting 2 4 (10)
   Itch/rash 0 2 (5)
   Muscle ache 3 (3) 5 (12)
   Eye swelling 0 1 (2)
   Scrotal pain/swelling 2 (2) 4 (10)
   Dyspnea 0 2 (5)
*

p<0.05

§

Auricular temperature ≥37.5°C. The highest temperature recorded post-treatment was 41.1°C.

Defined as a change in blood pressure of 30 mm Hg systolic or 20 mm Hg diastolic compared to the pre-treatment recording. Three of five individuals in the IVM+DEC+ALB group had reduced blood pressure. All four individuals in the DEC+ALB group had reduced blood pressure.

Only grade 2 or 3 AEs are listed by symptoms. All but one participant with grade 2 symptoms had more than one AE.

***

p<0.001 by chi-square