Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127757451 | 12775745 | 1 | I | 20141127 | 20150205 | 20160923 | 20160923 | EXP | GB-MHRA-ADR 22857609 | GB-PFIZER INC-2746457 | PFIZER | 60.00 | YR | M | Y | 85.00000 | KG | 20160923 | OT | GB | GB |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127757451 | 12775745 | 1 | PS | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | OXMDG REGIME | U | 8107 | ||||||||||
| 127757451 | 12775745 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 640 MG, UNK | M130868A | 0 | 640 | MG | |||||||
| 127757451 | 12775745 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 5000 MG, UNK | M130868A | 0 | 5000 | MG | |||||||
| 127757451 | 12775745 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 3800 MG, OXMDGREGIME, INLV5PUMP,FREQ: 1 HOUR; INTERVAL: 46 | M130868A | 0 | 3800 | MG | |||||||
| 127757451 | 12775745 | 5 | SS | BAXTER SALINE | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 100 ML, 0.90%; INFUSED OVER 46 HOURS | U | 14H19136 | 0 | 100 | ML | SOLUTION FOR INFUSION | |||||
| 127757451 | 12775745 | 6 | SS | OXALIPLATIN FRESENIUS KABI | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 135 MG, ONCE; OXMDG REGIME | Y | 9385841 | 0 | 135 | MG | ||||||
| 127757451 | 12775745 | 7 | C | EMEND | APREPITANT | 1 | 125 MG, ONCE | 0 | 125 | MG | |||||||||
| 127757451 | 12775745 | 8 | C | EMEND | APREPITANT | 1 | Oral | 80 MG, FREQ: 1 DAY; INTERVAL: 1 | 0 | 80 | MG | ||||||||
| 127757451 | 12775745 | 9 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 150 MG, FREQ: 2 DAY; INTERVAL: 1 | 0 | 150 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127757451 | 12775745 | 2 | Colorectal cancer |
| 127757451 | 12775745 | 5 | Colorectal cancer |
| 127757451 | 12775745 | 6 | Colorectal cancer |
| 127757451 | 12775745 | 7 | Nausea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127757451 | 12775745 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127757451 | 12775745 | Cough | |
| 127757451 | 12775745 | Decreased appetite | |
| 127757451 | 12775745 | Device infusion issue | |
| 127757451 | 12775745 | Fatigue | |
| 127757451 | 12775745 | Headache | |
| 127757451 | 12775745 | Incorrect drug administration rate | |
| 127757451 | 12775745 | Malaise | |
| 127757451 | 12775745 | Mood swings | |
| 127757451 | 12775745 | Neuropathy peripheral | |
| 127757451 | 12775745 | Oral pain |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127757451 | 12775745 | 1 | 20141126 | 0 | ||
| 127757451 | 12775745 | 2 | 20141126 | 0 | ||
| 127757451 | 12775745 | 3 | 20141222 | 0 | ||
| 127757451 | 12775745 | 4 | 20150113 | 0 | ||
| 127757451 | 12775745 | 5 | 20141126 | 0 | ||
| 127757451 | 12775745 | 6 | 20141126 | 0 | ||
| 127757451 | 12775745 | 7 | 20141126 | 20141126 | 0 | |
| 127757451 | 12775745 | 8 | 20141128 | 0 |