Table 5

List of adverse events

Adverse event numberGroupAdverse eventOutcomeSeverityRelationship to study productComments
1Immediate antibiotics aloneTummy upset that started 3 days after starting ciprofloxacin (second course of antibiotics)ResolvedMildNot relatedNot applicable
2Immediate antibiotics aloneReaction after taking one dose of antibioticResolvedUncertainNot relatedNot applicable
3Immediate antibiotics and immediate cranberrySuprapubic pain, dysuria, backache, cloudy urine and single vomitResolvedModeratePossibly relatedPossible pyelonephritis from description of symptoms, although not reported as such by healthcare practitioner. MSU positive—Escherichia coli 10⁵ CFU/mL.
4Immediate antibiotics and immediate cranberryVomiting after second course of nitrofurantoin startedResolvedMildPossibly relatedVomit after second course of antibiotics started. Antibiotics stopped and participant encouraged to push fluids. Symptoms settled without further antibiotics being prescribed.
5Immediate cranberry and delayed antibioticsFeeling unwell, ache in lower backResolvedModeratePossibly relatedSymptoms unlikely to be related to the study product, as the participant was recruited in the morning and the symptoms started the same day in the afternoon. Participant reported feeling fully recovered on day 2 and did not contact healthcare practitioner up to 28 days. MSU positive >E.coli 10⁵ CFU/mL.
6Immediate cranberry and delayed antibioticsFelt sickResolvedMildPossibly relatedParticipant mentioned that she was unsure whether the sickness symptom was related to cranberry or her UTI.
7Immediate cranberry and delayed antibioticsGeneral feeling of being unwell, terrible backache and stomachache at times, headache and nauseaResolvedModeratePossibly relatedPossible pyelonephritis, however, no growth on MSU, reported feeling fully recovered on day 5, and the participant did not contact a healthcare practitioner up to 28 days.

  • CFU, colony-forming unit; MSU, midstream urine; UTI, urinary tract infection.