Description of Event or Problem · 0
SUBJECT (B)(6) IS A 66-YEAR-OLD MALE WITH OROPHARYNGEAL SCC WHO WAS RANDOMIZED (TO ANN A CRT/ NIVOLURNAB AND INITIATED TREATMENT ON MCC20274/EA3161 ON (B)(6) 2024. THE SUBJECT IS CURRENTLY ONE WEEK POST CYCLE CRT WK 7, RECEIVING A TOTAL OF: 5 DOSES OF CISPLATIN (B)(6)2024, (B)(6) 2024, (B)(6) 2024, (B)(6) 2024, (B)(6) 2024) WEEKS 1,3,4,5,6 CISPLATIN GIVEN. WEEKS 2 AND 7 CISPALTIN NOT GIVEN.) THE FOLLOWING EVENT(S) OCCURRED: SAE EVENT: INJURY, POISONING AND PROCEDURAL COMPLICATIONS. THIS EVENT STARTED ON: (B)(6) 2024. PATIENT WAS ADMITTED INPATIENT (B)(6) 2024 FOR ESOPHAGITIS. ON (B)(6) 2024 A G TUBE WAS PLACED DUE TO ESOPHAGITIS AND PATIENT WAS GIVEN AN EXPECTED DISCHARGE DATE OF (B)(6) 2024. ON (B)(6) 2024 THE SUBJECT REPORTED PAIN DURING WATER FLUSH OF TUBE. A CT REVEALED THE G TUBE WAS IN THE PERITONEUM. THE G TUBE WAS REMOVED. A PICC LINE WAS PLACED FOR TOTAL PARENTERAL NUTRITION. ON (B)(6) 2024 A NEW G TUBE WAS PLACED. AS OF TODAY, (B)(6) 2024, THE SUBJECT IS STILL INPATIENT DUE TO THE G TUBE CHANGE AND THUS PROLONGED HIS HOSPITALIZATION. THIS EVENT WILL BE UPDATED ONCE THE PATIENT HAS BEEN DISCHARGED. GR.3 INJURY. POISONING AND PROCEDURAL COMPLICATIONS - "OTL".