Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

It's still my belief that the below chart of SAE's includes all issues from radiation, Cisplatin and Brilacidin oral rinse. Adverse events may or may not be caused by the intervention/treatment being studied. But, all should be listed.

Adverse events definition in clinical trials glossary. On a side panel that opened up when clicking on Adverse Events on this page.
https://clinicaltrials.gov/ct2/help/how-read-study#Results

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.

Eligibility for trial inclueded requirement for radiation treatmen and weekly or every 21 days Cisplation treatment.

Brilacidin treatment was oral rinse and likely treated at home for most of the trial. Following statement is found in exclusion criteria:

20 Is unwilling or unable to agree to swish and spit the study oral rinse three times per day during the study period

https://clinicaltrials.gov/ct2/show/record/NCT02324335?term=brilacidin&draw=1&rank=1

3. Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiation dose ≥55 Gy and ≤72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate). [Note: the independent RTQA consultant must confirm that the planned radiation treatment meets the protocol criteria]
4. Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)

Since all things are included whether or not they have anything to do with the studied drup I've become further convinced that the following chart of SAE's include those from radiation and Cisplatin in addition to Brialacidin.

Plus, most of the Brilacidin usage was at home. Patients only went into hospital or clinic for radiation or Cisplatin treatments. This reduces likelyhood of catheter site cellulitis from Brilacidin rinse even more unlikely