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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123553065 | 12355306 | 5 | F | 20160413 | 20160824 | 20160511 | 20160907 | EXP | GB-PFIZER INC-2016229433 | PFIZER | 68.00 | YR | M | Y | 68.00000 | KG | 20160907 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123553065 | 12355306 | 1 | SS | MSB0010718C | AVELUMAB | 1 | Intravenous (not otherwise specified) | 10 MG/KG, CYCLIC (ONCE EVERY 2 WEEKS) | Y | 0 | 10 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 123553065 | 12355306 | 2 | PS | VARENICLINE TARTRATE | VARENICLINE TARTRATE | 1 | Oral | 0.5 MG, 1X/DAY | 22 | MG | Y | 21928 | .5 | MG | QD | ||||
| 123553065 | 12355306 | 3 | SS | VARENICLINE TARTRATE | VARENICLINE TARTRATE | 1 | Oral | 0.5 MG, 2X/DAY | 22 | MG | Y | 21928 | .5 | MG | BID | ||||
| 123553065 | 12355306 | 4 | SS | VARENICLINE TARTRATE | VARENICLINE TARTRATE | 1 | Oral | 1 MG, 2X/DAY | 22 | MG | Y | 21928 | 1 | MG | BID | ||||
| 123553065 | 12355306 | 5 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 500 MG, UNK | 0 | 500 | MG | |||||||||
| 123553065 | 12355306 | 6 | C | CHLORPHENIRAMINE /00072501/ | CHLORPHENIRAMINE | 1 | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 123553065 | 12355306 | 7 | C | NAPROXEN. | NAPROXEN | 1 | Oral | 250 MG, 2X/DAY | 0 | 250 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123553065 | 12355306 | 1 | Transitional cell carcinoma |
| 123553065 | 12355306 | 2 | Smoking cessation therapy |
| 123553065 | 12355306 | 5 | Premedication |
| 123553065 | 12355306 | 6 | Premedication |
| 123553065 | 12355306 | 7 | Arthralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123553065 | 12355306 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123553065 | 12355306 | Drug-induced liver injury |
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 |
|---|---|---|---|---|---|---|
| 123553065 | 12355306 | 1 | 20150722 | 20160330 | 0 | |
| 123553065 | 12355306 | 2 | 20160323 | 20160325 | 0 | |
| 123553065 | 12355306 | 3 | 20160326 | 20160329 | 0 | |
| 123553065 | 12355306 | 4 | 20160330 | 20160406 | 0 | |
| 123553065 | 12355306 | 5 | 20160330 | 0 | ||
| 123553065 | 12355306 | 6 | 20160330 | 0 | ||
| 123553065 | 12355306 | 7 | 20151117 | 0 |