Table 2: Adverse event reporting.

GradeFrequencyDoseDescriptionRelationExpectation

Mild73 gHeartburnPossibly relatedUnexpected
3 gHeart palpitationsUnlikely relatedUnexpected
6 gConstipationUnlikely relatedUnexpected
6 gChest painPossibly relatedUnexpected
6 gFever with concomitant R dermatitis (2)Unlikely relatedUnexpected
9 gCold or Flu-like symptomsUnlikely relatedUnexpected

Moderate16 gFatigue; secondary to UT infectionUnlikely relatedUnexpected

Severe16 gAnxiety eventPossibly relatedUnexpected

Total9