Table 5. Outcomes according to phase.

Phase	Primary endpoint(s)	Secondary endpoint(s)
II	Adverse events of special interest (AESI) Serious adverse events (SAE) Pharmacokinetic analyses	Drug-drug interactions Treatment interruption (tolerability) Mortality and disability Biomarkers of treatment response (pathogen and host inflammation)
III	Mortalitya at 12 mo. Disability by MRS at 12 mo.	Change in GCS or MRC grade Change in neuroimaging Occurrence of new events Occurrence of paradoxical deterioration or TBM-IRIS Cognitive status at 12 mo. SAE with grade and relatedness Duration of hospitalisation AESI Treatment interruption (with reason and duration) Health Economic (improvement in DALY and QALY)

^aAll cause and attributable to TBM

DALY = Disability adjusted life year(s)

EOT = End of treatment

GCS = Glasgow coma scale

MRS = Modified Rankin scale

QALY = Quality adjusted life year(s)

TBM-IRIS = HIV-tuberculosis associated immune reconstitution inflammatory syndrome Table based on ^12,15.