Table 1. Standard analyses and reporting of clinical and virological endpoints in early-phase trials of dengue therapeutics.

Variable*	Endpoint to report for each treatment arm
Adverse events	Listings and summaries of adverse and severe adverse events with reference to standard definitions (e.g. Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (Cancer Therapy Evaluation Program, NIH)).
Fever	Fever clearance time—defined as the time from the start of treatment to the start of the first 24-h period during which the tympanic or oral temperature remains below 37.5°C (with 6-hourly measurements).
Hemorrhage	Proportions of patients with mild, moderate, or severe bleeding according to the following definitions:MILD: petechiae and/or minor self-limiting mucosal bleeding that does not require an intervention (e.g. minor nose bleeds, gum bleeds)MODERATE: by clinical judgement, more severe skin or mucosal bleeding but not requiring a transfusion or fluid resuscitation (e.g. small haematemesis or widespread bruising/ecchymoses)SEVERE: bleeding causing haemodynamic compromise requiring fluid resuscitation or use of blood products; any intracranial bleed (regardless of need for fluids); any bleed causing death
Virological features	Area under the log-transformed viremia curve from first dose to the end of study day 7 (AUC)aTime to resolution of viremia (<1000 copies/ml)aTime to resolution of plasma NS1 antigenemia—defined as the first time NS1 becomes undetectable in plasma
Capillary permeability	Maximum % hemoconcentration—determined by comparison of the maximum Hct detected in the acute phase and a baseline measurement or an age/gender matched population value
Hematology	Minimum platelet count during the critical phaseMaximum aPTT during the critical phaseMaximum INR during the critical phaseMinimum fibrinogen during the critical phase
Biochemistry	Highest hepatic transaminase levels (AST/ALT)

^*Comparisons of laboratory and virological features between study groups should be adjusted for the baseline value, the day of illness on admission, and serotype/serology (for virological features) to maximize power.

^aAUC calculated based on the trapezoidal rule with values below the limit of detection replaced by half of the detection limit.