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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126611621 | 12661162 | 1 | I | 20151027 | 20160804 | 20160817 | 20160817 | EXP | CH-TEVA-683665ISR | TEVA | 0.00 | YR | F | Y | 2.44000 | KG | 20160817 | MD | CH | CH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126611621 | 12661162 | 1 | PS | Epirubicin | EPIRUBICIN | 1 | Transplacental | 90 MG/M2 DAILY; | 65331 | 90 | MG/M**2 | ||||||||
| 126611621 | 12661162 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Transplacental | 80 MG/M2 DAILY; | 75297 | 80 | MG/M**2 | 1X | |||||||
| 126611621 | 12661162 | 3 | SS | Mephamesone | DEXAMETHASONE | 1 | Transplacental | 8 MILLIGRAM DAILY; | 0 | 8 | MG | QD | |||||||
| 126611621 | 12661162 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Transplacental | 600 MG/M2 DAILY; | 0 | 600 | MG/M**2 | ||||||||
| 126611621 | 12661162 | 5 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Transplacental | 62.5 MILLIGRAM DAILY; | 0 | 62.5 | MG | ||||||||
| 126611621 | 12661162 | 6 | SS | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Transplacental | .25 MILLIGRAM DAILY; | 0 | .25 | MG | ||||||||
| 126611621 | 12661162 | 7 | SS | EMEND | APREPITANT | 1 | Transplacental | 0 | |||||||||||
| 126611621 | 12661162 | 8 | SS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Transplacental | 50 MILLIGRAM DAILY; | 0 | 50 | MG | QD | |||||||
| 126611621 | 12661162 | 9 | SS | Tavegyl | CLEMASTINE FUMARATE | 1 | Transplacental | 2 MILLIGRAM DAILY; | 0 | 2 | MG | 1X | |||||||
| 126611621 | 12661162 | 10 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | 8 MILLIGRAM DAILY; | 0 | 8 | MG | 1X |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126611621 | 12661162 | 1 | Breast cancer |
| 126611621 | 12661162 | 2 | Breast cancer |
| 126611621 | 12661162 | 3 | Drug reaction with eosinophilia and systemic symptoms |
| 126611621 | 12661162 | 4 | Breast cancer |
| 126611621 | 12661162 | 5 | Prophylaxis of nausea and vomiting |
| 126611621 | 12661162 | 6 | Prophylaxis of nausea and vomiting |
| 126611621 | 12661162 | 7 | Prophylaxis of nausea and vomiting |
| 126611621 | 12661162 | 8 | Drug reaction with eosinophilia and systemic symptoms |
| 126611621 | 12661162 | 9 | Drug reaction with eosinophilia and systemic symptoms |
| 126611621 | 12661162 | 10 | Prophylaxis of nausea and vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126611621 | 12661162 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126611621 | 12661162 | Exposure during pregnancy | |
| 126611621 | 12661162 | Premature baby |
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 |
|---|---|---|---|---|---|---|
| 126611621 | 12661162 | 1 | 20151027 | 20151228 | 0 | |
| 126611621 | 12661162 | 2 | 20160121 | 20160121 | 0 | |
| 126611621 | 12661162 | 3 | 20160121 | 20160121 | 0 | |
| 126611621 | 12661162 | 4 | 20151027 | 20151228 | 0 | |
| 126611621 | 12661162 | 5 | 20151027 | 20151228 | 0 | |
| 126611621 | 12661162 | 6 | 20151027 | 20151228 | 0 | |
| 126611621 | 12661162 | 7 | 20151027 | 20151118 | 0 | |
| 126611621 | 12661162 | 8 | 20160121 | 20160121 | 0 | |
| 126611621 | 12661162 | 9 | 20160121 | 20160121 | 0 | |
| 126611621 | 12661162 | 10 | 20160121 | 20160121 | 0 |