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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125456851 | 12545685 | 1 | I | 20160621 | 20160627 | 20160711 | 20160711 | EXP | IT-IGI LABORATORIES, INC.-1054858 | IGI LABORATORIES | 56.00 | YR | M | Y | 0.00000 | 20160711 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125456851 | 12545685 | 1 | PS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 19090 | 50 | MG | SOLUTION FOR INJECTION | ||||||||
| 125456851 | 12545685 | 2 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | |||||||||||
| 125456851 | 12545685 | 3 | C | Desametasone | DEXAMETHASONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125456851 | 12545685 | 1 | Prophylaxis against gastrointestinal ulcer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125456851 | 12545685 | LT |
| 125456851 | 12545685 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125456851 | 12545685 | Asthenia | |
| 125456851 | 12545685 | Dyspnoea | |
| 125456851 | 12545685 | Erythema | |
| 125456851 | 12545685 | Heart rate increased | |
| 125456851 | 12545685 | Hyperhidrosis | |
| 125456851 | 12545685 | Hypotension | |
| 125456851 | 12545685 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 125456851 | 12545685 | 1 | 20160621 | 20160621 | 0 | |
| 125456851 | 12545685 | 2 | 20160621 | 20160621 | 0 | |
| 125456851 | 12545685 | 3 | 20160621 | 20160621 | 0 |