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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125403281 | 12540328 | 1 | I | 20160623 | 20160708 | 20160708 | EXP | BE-CIPLA LTD.-2016BE08778 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125403281 | 12540328 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | (AUC) 10 ON DAYS -7, -5, AND -3 | U | U | 77383 | ||||||||
| 125403281 | 12540328 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | 4 AUCS PER WEEK ON DAY 1 AND DAY 8, EVERY 3 WEEKS) WAS GIVEN FOR 4 CYCLES | U | U | 77383 | ||||||||
| 125403281 | 12540328 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 75 MG/M2, ON DAY 1 | U | 0 | 75 | MG/M**2 | |||||||
| 125403281 | 12540328 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 150 MG/M2, ON DAY 1 | U | U | 0 | 150 | MG/M**2 | ||||||
| 125403281 | 12540328 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 100 MG/M2, UNK | U | U | 0 | 100 | MG/M**2 | ||||||
| 125403281 | 12540328 | 6 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 100 MG/M2, WEEKLY | U | U | 0 | 100 | MG/M**2 | ||||||
| 125403281 | 12540328 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 450 MG/M2 UNK | U | U | 0 | 450 | MG/M**2 | ||||||
| 125403281 | 12540328 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 300 MG/M2, UNK | U | U | 0 | 300 | MG/M**2 | ||||||
| 125403281 | 12540328 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 1000 MG/M2,WEEKLY | U | U | 0 | 1000 | MG/M**2 | ||||||
| 125403281 | 12540328 | 10 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 75 MG/M2, UNK | U | U | 0 | 75 | MG/M**2 | ||||||
| 125403281 | 12540328 | 11 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 90 MG/M2, WEEKLY | U | U | 0 | 90 | MG/M**2 | ||||||
| 125403281 | 12540328 | 12 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 60 MG/M2 ON DAYS 5 AND 3 | U | U | 0 | 60 | MG/M**2 | ||||||
| 125403281 | 12540328 | 13 | SS | Dactinomycin | DACTINOMYCIN | 1 | Intravenous (not otherwise specified) | 0.5 MG , ON DAY 8 | U | 0 | .5 | MG | |||||||
| 125403281 | 12540328 | 14 | SS | MESNA. | MESNA | 1 | Unknown | UNK ON DAYS 5 AND 3 | U | U | 0 | ||||||||
| 125403281 | 12540328 | 15 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 30 MG, BID, ON DAYS 0-14 | U | U | 0 | 30 | MG | ||||||
| 125403281 | 12540328 | 16 | C | Ondasetron | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | U | U | 0 | 8 | MG | ||||||
| 125403281 | 12540328 | 17 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 125 MG, UNK | U | U | 0 | 125 | MG | ||||||
| 125403281 | 12540328 | 18 | C | Glucose | DEXTROSE | 1 | Intravenous (not otherwise specified) | 1 LITRE | U | U | 0 | 1 | L | ||||||
| 125403281 | 12540328 | 19 | C | Magnesium sulphate | MAGNESIUM SULFATE | 1 | Unknown | 3 G, UNK | U | U | 0 | 3 | G | ||||||
| 125403281 | 12540328 | 20 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Intravenous (not otherwise specified) | 500 ML | U | U | 0 | 500 | ML | ||||||
| 125403281 | 12540328 | 21 | C | Folinic acid | LEUCOVORIN | 1 | Unknown | 7.5 MG | U | U | 0 | 7.5 | MG | ||||||
| 125403281 | 12540328 | 22 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 100 MG, TID ON DAYS 8 TO 10 | U | U | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125403281 | 12540328 | 1 | Malignant hydatidiform mole |
| 125403281 | 12540328 | 3 | Malignant hydatidiform mole |
| 125403281 | 12540328 | 4 | Malignant hydatidiform mole |
| 125403281 | 12540328 | 8 | Malignant hydatidiform mole |
| 125403281 | 12540328 | 10 | Malignant hydatidiform mole |
| 125403281 | 12540328 | 12 | Malignant hydatidiform mole |
| 125403281 | 12540328 | 13 | Malignant hydatidiform mole |
| 125403281 | 12540328 | 16 | Antiemetic supportive care |
| 125403281 | 12540328 | 17 | Prophylaxis |
| 125403281 | 12540328 | 20 | Urine alkalinisation therapy |
| 125403281 | 12540328 | 21 | Toxicity to various agents |
| 125403281 | 12540328 | 22 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125403281 | 12540328 | OT |
| 125403281 | 12540328 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125403281 | 12540328 | Disease progression | |
| 125403281 | 12540328 | Disease recurrence | |
| 125403281 | 12540328 | Drug ineffective | |
| 125403281 | 12540328 | Ototoxicity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |