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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125870862 | 12587086 | 2 | F | 20160624 | 20160719 | 20160725 | 20160802 | EXP | IT-CIPLA LTD.-2016IT09772 | CIPLA | 0.00 | Y | 0.00000 | 20160802 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125870862 | 12587086 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | UNK | U | U | 0 | SOLUTION FOR INJECTION | |||||||
| 125870862 | 12587086 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 1000 MG/MQ OF BODY SURFACE/CYCLICAL | U | U | 0 | SOLUTION FOR INJECTION | |||||||
| 125870862 | 12587086 | 3 | SS | Cetuximab | CETUXIMAB | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125870862 | 12587086 | 4 | C | Soldesam | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 20 MG, UNK | U | U | 0 | 20 | MG | ||||||
| 125870862 | 12587086 | 5 | C | Lonquex | LIPEGFILGRASTIM | 1 | Subcutaneous | UNK | U | U | 0 | ||||||||
| 125870862 | 12587086 | 6 | C | Ondansetron | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | U | U | 0 | 8 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125870862 | 12587086 | 1 | Product used for unknown indication |
| 125870862 | 12587086 | 2 | Product used for unknown indication |
| 125870862 | 12587086 | 3 | Product used for unknown indication |
| 125870862 | 12587086 | 4 | Product used for unknown indication |
| 125870862 | 12587086 | 5 | Product used for unknown indication |
| 125870862 | 12587086 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125870862 | 12587086 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125870862 | 12587086 | Febrile bone marrow aplasia | |
| 125870862 | 12587086 | Medication error | |
| 125870862 | 12587086 | Mucosal inflammation | |
| 125870862 | 12587086 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 125870862 | 12587086 | 1 | 20160616 | 20160616 | 0 | |
| 125870862 | 12587086 | 2 | 20160616 | 20160618 | 0 | |
| 125870862 | 12587086 | 3 | 20160616 | 20160623 | 0 | |
| 125870862 | 12587086 | 4 | 20160616 | 20160616 | 0 | |
| 125870862 | 12587086 | 5 | 20160618 | 20160618 | 0 | |
| 125870862 | 12587086 | 6 | 20160616 | 20160616 | 0 |