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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122021095 | 12202109 | 5 | F | 20160627 | 20160322 | 20160705 | EXP | JP-SA-2016SA053620 | AVENTIS | 32.00 | YR | A | M | Y | 81.00000 | KG | 20160705 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122021095 | 12202109 | 1 | PS | ELPLAT | OXALIPLATIN | 1 | Intravenous drip | FREQUENCY: 1 EVERY 3 WEEKS?TWO CYCLES EVERY 3 WEEKS?MODIFIED BEP REGIMEN (DAY 10) | Y | UNKNOWN | 21759 | 130 | MG/M**2 | INJECTION | |||||
| 122021095 | 12202109 | 2 | SS | BLEOMYCIN | BLEOMYCIN SULFATE | 1 | Intravenous (not otherwise specified) | FORM: INFUSION | UNKNOWN | 0 | 25 | MG | QD | ||||||
| 122021095 | 12202109 | 3 | SS | BLEOMYCIN | BLEOMYCIN SULFATE | 1 | Unknown | FREQUENCY: 1 EVERY 3 WEEKS?TWO CYCLES EVERY 3 WEEKS | UNKNOWN | 0 | 30 | MG/M**2 | |||||||
| 122021095 | 12202109 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | DOSE:41.1 MG/BODY (20 MG/M2)?FREQUENCY: 1 EVERY 3 WEEKS?TWO CYCLES EVERY 3 WEEKS | UNKNOWN | 0 | 20 | MG/M**2 | INJECTION | ||||||
| 122021095 | 12202109 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | DOSE:41.1 MG/BODY (20 MG/M2)?FREQUENCY: 1 EVERY 3 WEEKS | UNKNOWN | 0 | 100 | MG/M**2 | INJECTION | ||||||
| 122021095 | 12202109 | 6 | C | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 0 | 175 | MG/M**2 | INJECTION | ||||||||
| 122021095 | 12202109 | 7 | C | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | DOSE:205.5 MG/BODY (100 MG/M2)?FREQUENCY: ONE EVERY 3 WEEKS?TWO CYCLES EVERY 3 WEEKS | 0 | 100 | MG/M**2 | INJECTION | |||||||
| 122021095 | 12202109 | 8 | C | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | DOSE:4110 MG/BODY (2000 MG/M2)?2 G/M2 ON DAYS 10, 12, AND 14 | 0 | 2000 | MG/M**2 | INJECTION | |||||||
| 122021095 | 12202109 | 9 | C | MESNA. | MESNA | 1 | Unknown | FREQUENCY: 1 EVERY 3 WEEKS | 0 | INJECTION | |||||||||
| 122021095 | 12202109 | 10 | C | GRANULOCYTE COLONY STIMULATING FACTOR | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | FREQUENCY: ONE EVERY 3 WEEKS?TWO CYCLES EVERY 3 WEEKS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122021095 | 12202109 | 1 | Choriocarcinoma |
| 122021095 | 12202109 | 2 | Metastatic choriocarcinoma |
| 122021095 | 12202109 | 3 | Metastatic choriocarcinoma |
| 122021095 | 12202109 | 4 | Metastatic choriocarcinoma |
| 122021095 | 12202109 | 5 | Metastatic choriocarcinoma |
| 122021095 | 12202109 | 6 | Metastatic choriocarcinoma |
| 122021095 | 12202109 | 7 | Choriocarcinoma |
| 122021095 | 12202109 | 8 | Metastatic choriocarcinoma |
| 122021095 | 12202109 | 9 | Prophylaxis |
| 122021095 | 12202109 | 10 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122021095 | 12202109 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122021095 | 12202109 | Acute kidney injury | |
| 122021095 | 12202109 | Decreased appetite | |
| 122021095 | 12202109 | Hyperuricaemia | |
| 122021095 | 12202109 | Malaise | |
| 122021095 | 12202109 | Product use issue | |
| 122021095 | 12202109 | Tumour lysis syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |