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Number (%) of subjects with adverse events by adverse event category, with Mazzotti reactions for which Fisher's exact text between at least one moxidectin treatment group and ivermectin treatment group yielded p-value<0.05 and for SSPH (mITT population).

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posted on 2014-06-26, 02:53 authored by Kwablah Awadzi, Nicholas O. Opoku, Simon K. Attah, Janis Lazdins-Helds, Annette C. Kuesel

UnAE Adverse event unrelated to study drug or study participation. ADR Adverse drug reaction, MAZ Mazzotti reaction, MAP mean arterial pressure: Diastolic pressure+1/3 (Systolic pressure - Diastolic Pressure).

1

2 mg: Anaemia from 144 days post-treatment, 4 mg: prolonged prothrombin time from 549 days post-treatment, haematuria 390 days post-treatment, 8 mg: prolonged prothrombin time 32 days after treatment.

2

After standing still for 2 minutes following at least 5 minutes supine.

3

SAPH severe asymptomatic postural hypotension, asymptomatic decrease in MAP by ≥35 mmHg relative to baseline after 2 min standing still following ≥5 minutes supine.

4

SSPH severe symptomatic postural hypotension, diagnosed when a subject cannot stand still for 2 minutes after ≥5 minutes supine due to drop in blood pressure.

* p<0.05 for pairwise comparison of moxidectin treatment group vs. ivermectin treatment group.

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