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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125400321 | 12540032 | 1 | I | 20121023 | 20160708 | 20160708 | EXP | BE-CIPLA LTD.-2013BE00144 | CIPLA | 0.00 | Y | 0.00000 | 20160708 | OT | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125400321 | 12540032 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC 5 | 77383 | ||||||||||
| 125400321 | 12540032 | 2 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 150 MG/M2, ON DAY 1 | 0 | 150 | MG/M**2 | ||||||||
| 125400321 | 12540032 | 3 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 100 MG/M2, ON DAY 8 | 0 | 100 | MG/M**2 | ||||||||
| 125400321 | 12540032 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 100 MG/M2, UNK | 0 | 100 | MG/M**2 | ||||||||
| 125400321 | 12540032 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 75 MG/M2, ON DAY 1 | Y | U | 0 | 75 | MG/M**2 | ||||||
| 125400321 | 12540032 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 300 MG/M2, UNK | 0 | 300 | MG/M**2 | ||||||||
| 125400321 | 12540032 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 1000 MG/M2, UNK | 0 | 1000 | MG/M**2 | ||||||||
| 125400321 | 12540032 | 8 | SS | DACTINOMYCIN-D | DACTINOMYCIN | 1 | Intravenous (not otherwise specified) | 0.5 MG, ON DAY 8 | 0 | .5 | MG | ||||||||
| 125400321 | 12540032 | 9 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 125 MG, UNK | U | U | 0 | 125 | MG | ||||||
| 125400321 | 12540032 | 10 | C | Ondasetron | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | U | U | 0 | 8 | MG | ||||||
| 125400321 | 12540032 | 11 | C | Granulocyte colony-stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125400321 | 12540032 | 1 | Metastatic choriocarcinoma |
| 125400321 | 12540032 | 2 | Metastatic choriocarcinoma |
| 125400321 | 12540032 | 5 | Metastatic choriocarcinoma |
| 125400321 | 12540032 | 6 | Metastatic choriocarcinoma |
| 125400321 | 12540032 | 8 | Metastatic choriocarcinoma |
| 125400321 | 12540032 | 9 | Prophylaxis of nausea and vomiting |
| 125400321 | 12540032 | 10 | Prophylaxis of nausea and vomiting |
| 125400321 | 12540032 | 11 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125400321 | 12540032 | DE |
| 125400321 | 12540032 | OT |
| 125400321 | 12540032 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125400321 | 12540032 | Coma | |
| 125400321 | 12540032 | Disease progression | |
| 125400321 | 12540032 | Endocarditis | |
| 125400321 | 12540032 | Hyperosmolar state | |
| 125400321 | 12540032 | Neutropenic sepsis | |
| 125400321 | 12540032 | Ototoxicity | |
| 125400321 | 12540032 | Pancytopenia | |
| 125400321 | 12540032 | Septic embolus |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |