Table 1

Six initial non-related serious adverse event (NR-SAE) cases

#NR-SAE diagnosis
(additional information)		Seriousness categoryTreatment locationDate of occurenceDate of reporting to siteOutcome
1Ovarian cysts; uterine myomas
(bilateral ovarian cystectomy and myomectomy)		HospitalisationCentre Hospitalier de l'excellence (1 km from trial site)5 Feb 202028 Mar 2020Discharged
15 Feb 2020
Recovered
15 Feb 2020
2Infectious enteritis; severe dehydration
(known HIV infection, poor medication adherence)		HospitalisationGeneral Reference Hospital of Boende (trial site)11 Feb 202011 Feb 2020Discharged
15 Feb 2020
Recovered
22 Feb 2020
3Lower limb fracture
(left leg, traffic accident)		HospitalisationGeneral Reference Hospital of Boende (trial site)12 Feb 202012 Feb 2020Discharged by family for traditional medicine
18 Feb 2020
Recovered/resolved with sequelae
15 Aug 2020
4Skin ulcers
(right thigh)		HospitalisationUndefined treatment location (25 km from trial site)18 Feb 202018 Mar 2020Discharged
18 Apr 2020
Recovered/resolved
20 Oct 2020
5Cerebrovascular accident: stroke
(severe hypertension)		HospitalisationGeneral Reference Hospital of Boende (trial site)15 Mar 202018 Mar 2020Discharged
20 Mar 2020
Recovered/resolved with sequelae
18 Mar 2020
6Severe malaria; typhoid feverHospitalisationCentre de Santé Espérances (1.5 km from trial site in Boende)30 Mar 202010 Apr 2020Discharged
02 Apr 2020
Recovered
02 Apr 2020

  • A blue highlight refers to an alternative treatment location than the study site. A yellow highlight refers to a different reporting date from the occurrence date.