Table 1.

PIVOTAL trial endpoints

Primary
A composite of nonfatal MI, nonfatal stroke, hospitalization for HF or death from any cause, analyzed as time-to-first event

Secondary (efficacy)	Secondary (safety)
- Total MI, stroke, hospitalization for HF and deaths, including first and recurrent events	- Vascular access thrombosis
- All-cause death	- All-cause hospitalization
- First composite cardiovascular event (MI, stroke, and hospitalization for HF)	- Hospitalization for infection
- Fatal or nonfatal MI	- Time to first and number of infection episodes
- Fatal or nonfatal stroke
- Heart failure hospitalization
- ESA dose requirements
- Transfusion requirements
- EuroQol-5D (EQ-5D)
- Kidney Disease Quality of Life (KDQOL) Instrument

Tertiary
- Cumulative dose of iron	- Platelet count
- Hemoglobin level	- Serum albumin level
- Serum ferritin level
- TSAT

HF, heart failure; MI, myocardial infarction; TSAT, transferrin saturation.