Table 1.
Number or AEs | AE Description | Intensity | Outcome | Relationship |
---|---|---|---|---|
Local adverse events | ||||
1 | Gross hematuria | Mild | Resolved | Not related |
1 | Irritable bowel flare | Mild | Resolved | Not related |
1 | Groin pull | Mild | Resolved | Not related |
1 | Bladder infection* | Mild | Resolved | Not related |
Other Adverse Events | ||||
1 | Nausea | Mild | Resolved | Not related |
1 | Elbow pinched nerve | Moderate | Resolved | Not related |
1 | Surgery Right arm | Moderate | Resolved | Not related |
1 | Yeast Infection | Moderate | Resolved | Not related |
1 | Pneumonia | Serious | Resolved | Not related |
AE occurred 4 weeks after final LP-08 instillation