Table 5.
Comparison of eflornithine monotherapy treatment (in the NECT clinical trial,7,8 and during routine use in the Ibba MSF treatment Centre, South Sudan),20 and NECT (in the NECT clinical trial7,8 and in routine use as monitored by WHO)
Eflornithine
|
NECT
|
|||||||
---|---|---|---|---|---|---|---|---|
NECT clinical trial
|
Control program Ibba (S. Sudan)
|
NECT clinical trial
|
Routine use PV system
|
|||||
n | % | n | % | n | % | n | % | |
Cases treated (n) | 143 | 1055 | 143 | 1735 | ||||
Cases with at least one AE | 134 | 93.7 | 962 | 91.2 | 134 | 93.7 | 1043 | 60.1 |
Cases with major clinical AE | 33 | 23.1 | 138 | 13.1 | 18 | 12.6 | 189 | 10.9 |
Cases with SAE | 6 | 4.2 | 1 | 0.7 | 19 | 1.1 | ||
Cases requiring treatment interruption | 9 | 6.3 | 109 | 10.3 | 45 | 2.6 | ||
Deaths during treatment | 3 | 2.1 | 16 | 1.5 | 1 | 0.7 | 9 | 0.5 |
Abbreviations: AE, adverse event; MSF, Médecins Sans Frontières; NECT, nifurtimox-eflornithine combination therapy; SAE, serious adverse event; WHO, World Health Organization.