Figure. Patient Recruitment, Randomization, and Follow-up in the LEAP 2 Trial.

ITT indicates intent to treat; LEAP 2, Lefamulin Evaluation Against Pneumonia 2.

^aThe number of patients with a Pneumonia Outcomes Research Team (PORT) risk class of II was capped at 50% of the total population; once this cap was reached, these patients were no longer assessed for study eligibility. All patients assessed for study eligibility provided informed consent.

^bOne patient did not attend the randomization visit, 1 patient did not receive study drug due to insufficient drug stock at site, 1 patient with PORT risk class II was assessed after the per-protocol cap had been met, 1 patient had prolonged QTcF at the screening visit, 2 patients were excluded by the investigator, 6 patients were excluded due to randomization error, and 1 patient was excluded for an unknown reason.

^cThe number of randomized patients who received a single dose of a short-acting antibiotic was capped at 25% of the total population; this cap was not reached and therefore this criterion had no effect on randomization.

^dPatients were discontinued from treatment because they met per protocol exclusion or study withdrawal criteria: 1 patient due to baseline and postbaseline QTcF greater than 500 ms, 2 patients due to confirmed Staphylococcus aureus bacteremia, and 1 patient due to a complete left bundle branch block.

^eMay have met more than 1 exclusion criterion.

^fAs defined by inclusion criteria 3 through 7 and exclusion criteria 3, 5, and 6 in Supplement 1.

^gAs defined by exclusion criterion 1 in Supplement 1.

^hPatient had a lung abscess diagnosed by computed tomography within hours after randomization.

ⁱOne patient was diagnosed with tuberculosis on study day 1; 1 patient was diagnosed with small cell lung cancer on study day 4; 1 patient was diagnosed with squamous cell carcinoma of the lung on study day 5; 1 patient was diagnosed with tuberculosis effusion on study day 24; and 1 patient was ultimately diagnosed with tuberculosis.