Table 2.

Interviewer reporting of post-baseline patient-reported symptoms.

Symptoms		Severity
Symptoms:	Symptoms findings (since the last visit)	If finding was 2−5, then enter severity a
For each of the 14 pre-specified symptoms:  Feeling feverish  Shaking/chills  Malaise  Frequency of urination  Urgency of urination  Dysuria (painful urination)  Urinary incontinence  Cloudy or change in color of urine  Nausea  Vomiting  Pain above the pubic bone  Abdominal pain  Flank/back/ costovertebral angle pain or tenderness  Back pain  Other b	□ 0 − Not present at last assessment □ 1 – Resolved or returned to the state before the UTI □ 2 – Not present at baseline/last assessment but new onset □ 3 – Continuing and increased since the last assessment □ 4 – Continuing but decreased since the last assessment □ 5 – Continuing and no change since the last assessment	□ MILD □ MODERATE □ SEVERE

UTI, urinary tract infection.

^aBased on the investigators’ clinical judgment, not pre-defined criteria for infection severity.

^bIf recorded at baseline visit or if considered by the investigator to be a new symptom related to complicated urinary tract infection at any visit.