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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121422262 | 12142226 | 2 | F | 20111031 | 20160222 | 20160303 | 20160720 | EXP | IT-MINISAL02-348363 | IT-MYLANLABS-2016M1008232 | MYLAN | 0.00 | Y | 0.00000 | 20160720 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121422262 | 12142226 | 1 | PS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 80 MG/M2, UNK | U | U | 91540 | 80 | MG/M**2 | SOLUTION FOR INJECTION | |||||
| 121422262 | 12142226 | 2 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 | ||||||||||||
| 121422262 | 12142226 | 3 | C | ASPIRINA | ASPIRIN | 1 | 0 | EFFERVESCENT TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121422262 | 12142226 | 1 | HER-2 positive gastric cancer |
| 121422262 | 12142226 | 2 | Product used for unknown indication |
| 121422262 | 12142226 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121422262 | 12142226 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121422262 | 12142226 | Abdominal pain upper | |
| 121422262 | 12142226 | Ascites | |
| 121422262 | 12142226 | Asthenia | |
| 121422262 | 12142226 | Haematemesis | |
| 121422262 | 12142226 | Haemoglobin decreased | |
| 121422262 | 12142226 | Malignant neoplasm progression | |
| 121422262 | 12142226 | Oedema peripheral | |
| 121422262 | 12142226 | Off label use | |
| 121422262 | 12142226 | Platelet count decreased |
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 |
|---|---|---|---|---|---|---|
| 121422262 | 12142226 | 1 | 20111031 | 0 |