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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126537511 | 12653751 | 1 | I | 20151027 | 20160804 | 20160816 | 20160816 | EXP | CH-BAXTER-2016BAX041697 | BAXTER | 0.00 | YR | F | Y | 2.44000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126537511 | 12653751 | 1 | PS | ENDOXAN 1 G | CYCLOPHOSPHAMIDE | 1 | Transplacental | MOTHER'S DOSE: 600 MG/M2, EC COURSE | 12142 | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||||
| 126537511 | 12653751 | 2 | SS | ENDOXAN 1 G | CYCLOPHOSPHAMIDE | 1 | Transplacental | MOTHER'S DOSE: 600 MG/M2, EC COURSE | 12142 | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||||
| 126537511 | 12653751 | 3 | SS | ENDOXAN 1 G | CYCLOPHOSPHAMIDE | 1 | Transplacental | MOTHER'S DOSE: 600 MG/M2, EC COURSE | 12142 | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||||
| 126537511 | 12653751 | 4 | SS | ENDOXAN 1 G | CYCLOPHOSPHAMIDE | 1 | Transplacental | MOTHER'S DOSE: 600 MG/M2, EC COURSE | 12142 | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||||
| 126537511 | 12653751 | 5 | SS | epirubicin | EPIRUBICIN | 1 | Transplacental | MOTHER'S DOSE: 90 MG/M2, EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 6 | SS | epirubicin | EPIRUBICIN | 1 | Transplacental | MOTHER'S DOSE: 90 MG/M2, EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 7 | SS | epirubicin | EPIRUBICIN | 1 | Transplacental | MOTHER'S DOSE: 90 MG/M2, EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 8 | SS | epirubicin | EPIRUBICIN | 1 | Transplacental | MOTHER'S DOSE: 90 MG/M2, EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 9 | SS | PACLITAXEL. | PACLITAXEL | 1 | Transplacental | MOTHER'S DOSE: 80 MG/M2, 5 COURSES IN TOTAL DURING PREGNANCY | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 10 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Transplacental | MOTHER'S DOSE: 62.5 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 11 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Transplacental | MOTHER'S DOSE: 62.5 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 12 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Transplacental | MOTHER'S DOSE: 62.5 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 13 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Transplacental | MOTHER'S DOSE: 62.5 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 14 | SS | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 0.25 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 15 | SS | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 0.25 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 16 | SS | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 0.25 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 17 | SS | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 0.25 MG, SINGLE DOSE ON DAY 1 OF EACH EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 18 | SS | EMEND | APREPITANT | 1 | Transplacental | MOTHER'S: DOSE: 125 MG, ON DAY 1 OF FIRST EC COURSE | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 19 | SS | EMEND | APREPITANT | 1 | Transplacental | MOTHER'S: DOSE: 80 MG, ON DAYS 2 AND 3 OF FIRST COURSE OF EC | 0 | UNSPECIFIED | |||||||||
| 126537511 | 12653751 | 20 | SS | EMEND | APREPITANT | 1 | Transplacental | MOTHER'S: DOSE: 125 MG, ON DAY 1 OF SECOND COURSE OF EC | 0 | UNSPECIFIED | /cycle | ||||||||
| 126537511 | 12653751 | 21 | SS | EMEND | APREPITANT | 1 | Transplacental | MOTHER'S: DOSE: 125 MG, ON DAYS 2 AND 3 OF SECOND COURSE OF EC | 0 | UNSPECIFIED | |||||||||
| 126537511 | 12653751 | 22 | SS | Mephamesone | DEXAMETHASONE | 1 | Transplacental | MOTHER'S DOSE: 8 MG, SINGLE DOSE ON DAY 1 OF PACLITAXEL | 0 | UNSPECIFIED | QD | ||||||||
| 126537511 | 12653751 | 23 | SS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 50 MG, SINGLE DOSE ON DAY 1 OF PACLITAXEL | 0 | UNSPECIFIED | QD | ||||||||
| 126537511 | 12653751 | 24 | SS | Tavegyl | CLEMASTINE FUMARATE | 1 | Transplacental | MOTHER'S DOSE: 2 MG, SINGLE DOSE ON DAY 1 OF PACLITAXEL | 0 | UNSPECIFIED | QD | ||||||||
| 126537511 | 12653751 | 25 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 8 MG, SINGLE DOSE ON DAY 1 OF PACLITAXEL | 0 | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126537511 | 12653751 | 1 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 5 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 9 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 10 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 14 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 18 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 22 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 23 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 24 | Foetal exposure timing unspecified |
| 126537511 | 12653751 | 25 | Foetal exposure timing unspecified |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126537511 | 12653751 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126537511 | 12653751 | Foetal exposure during pregnancy | |
| 126537511 | 12653751 | 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 |
|---|---|---|---|---|---|---|
| 126537511 | 12653751 | 1 | 20151027 | 0 | ||
| 126537511 | 12653751 | 2 | 20151116 | 0 | ||
| 126537511 | 12653751 | 3 | 20151207 | 0 | ||
| 126537511 | 12653751 | 4 | 20151228 | 0 | ||
| 126537511 | 12653751 | 5 | 20151027 | 0 | ||
| 126537511 | 12653751 | 6 | 20151116 | 0 | ||
| 126537511 | 12653751 | 7 | 20151207 | 0 | ||
| 126537511 | 12653751 | 8 | 20151228 | 0 | ||
| 126537511 | 12653751 | 9 | 20160121 | 0 | ||
| 126537511 | 12653751 | 10 | 20151027 | 0 | ||
| 126537511 | 12653751 | 11 | 20151116 | 0 | ||
| 126537511 | 12653751 | 12 | 20151207 | 0 | ||
| 126537511 | 12653751 | 13 | 20151228 | 0 | ||
| 126537511 | 12653751 | 14 | 20151027 | 0 | ||
| 126537511 | 12653751 | 15 | 20151116 | 0 | ||
| 126537511 | 12653751 | 16 | 20151207 | 0 | ||
| 126537511 | 12653751 | 17 | 20151228 | 0 | ||
| 126537511 | 12653751 | 18 | 20151027 | 0 | ||
| 126537511 | 12653751 | 20 | 20151116 | 0 | ||
| 126537511 | 12653751 | 21 | 20151118 | 0 | ||
| 126537511 | 12653751 | 22 | 20160121 | 20160121 | 0 | |
| 126537511 | 12653751 | 23 | 20160121 | 20160121 | 0 | |
| 126537511 | 12653751 | 24 | 20160121 | 20160121 | 0 | |
| 126537511 | 12653751 | 25 | 20160121 | 20160121 | 0 |