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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125419201 | 12541920 | 1 | I | 201605 | 20160627 | 20160708 | 20160708 | EXP | FR-IGI LABORATORIES, INC.-1054831 | IGI LABORATORIES | 59.00 | YR | F | Y | 0.00000 | 20160708 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125419201 | 12541920 | 1 | PS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | Y | 19090 | 50 | MG | SOLUTION FOR INFUSION | QD | ||||||
| 125419201 | 12541920 | 2 | SS | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | Y | 0 | 50 | MG | SOLUTION FOR INJECTION | QD | ||||||
| 125419201 | 12541920 | 3 | C | TAXOL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 125419201 | 12541920 | 4 | C | AVASTIN | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 125419201 | 12541920 | 5 | C | INNOHEP | TINZAPARIN SODIUM | 1 | Unknown | 0 | 1400 | IU | QD | ||||||||
| 125419201 | 12541920 | 6 | C | Solupred | PREDNISOLONE | 1 | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125419201 | 12541920 | 1 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125419201 | 12541920 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125419201 | 12541920 | Discomfort | |
| 125419201 | 12541920 | Dyspnoea | |
| 125419201 | 12541920 | Erythema | |
| 125419201 | 12541920 | Face oedema | |
| 125419201 | 12541920 | Headache | |
| 125419201 | 12541920 | Hyperhidrosis | |
| 125419201 | 12541920 | Hypotension | |
| 125419201 | 12541920 | Loss of consciousness | |
| 125419201 | 12541920 | Malaise | |
| 125419201 | 12541920 | Pain in jaw | |
| 125419201 | 12541920 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125419201 | 12541920 | 3 | 201512 | 0 | ||
| 125419201 | 12541920 | 4 | 201512 | 0 | ||
| 125419201 | 12541920 | 5 | 201512 | 0 | ||
| 125419201 | 12541920 | 6 | 20160325 | 20160328 | 0 |