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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931881 | 12693188 | 1 | I | 20140307 | 20160829 | 20160829 | EXP | JP-CIPLA LTD.-2016JP17479 | CIPLA | KUWANO H, TSUCHIYA T, MURAYAMA T, SANO A, NAGAYAMA K, YOSHIDA Y ET.AL. OUTCOMES OF COMBINED MODALITY THERAPY FOR PATIENTS WITH STAGE III OR IV MEDIASTINAL MALIGNANT GERM CELL TUMORS. SURG TODAY. 2014;44:499 TO 504 | 0.00 | Y | 0.00000 | 20160829 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931881 | 12693188 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | UNK | U | U | 77383 | ||||||||
| 126931881 | 12693188 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126931881 | 12693188 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126931881 | 12693188 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, FIRST LINE CHEMOTHERAPY | U | U | 0 | ||||||||
| 126931881 | 12693188 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126931881 | 12693188 | 6 | SS | BLEOMYCIN | BLEOMYCIN SULFATE | 1 | Unknown | UNK, FIRST LINE CHEMOTHERAPY, 3 CYCLES | U | U | 0 | ||||||||
| 126931881 | 12693188 | 7 | SS | BLEOMYCIN | BLEOMYCIN SULFATE | 1 | Unknown | UNK, 2 COURSES | U | U | 0 | ||||||||
| 126931881 | 12693188 | 8 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | UNK, FIRST LINE CHEMOTHERAPY | U | U | 0 | ||||||||
| 126931881 | 12693188 | 9 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | UNK, 2 COURSES | U | U | 0 | ||||||||
| 126931881 | 12693188 | 10 | SS | PACLITAXEL. | PACLITAXEL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126931881 | 12693188 | 11 | SS | Vinblastine | VINBLASTINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126931881 | 12693188 | 12 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126931881 | 12693188 | 13 | SS | Nedaplatin | NEDAPLATIN | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126931881 | 12693188 | 1 | Germ cell cancer |
| 126931881 | 12693188 | 2 | Germ cell cancer |
| 126931881 | 12693188 | 3 | Germ cell cancer |
| 126931881 | 12693188 | 4 | Germ cell neoplasm |
| 126931881 | 12693188 | 6 | Germ cell neoplasm |
| 126931881 | 12693188 | 8 | Germ cell neoplasm |
| 126931881 | 12693188 | 10 | Germ cell cancer |
| 126931881 | 12693188 | 11 | Germ cell cancer |
| 126931881 | 12693188 | 12 | Germ cell cancer |
| 126931881 | 12693188 | 13 | Germ cell cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126931881 | 12693188 | DE |
| 126931881 | 12693188 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126931881 | 12693188 | Disease recurrence | |
| 126931881 | 12693188 | Drug ineffective | |
| 126931881 | 12693188 | Metastasis | |
| 126931881 | 12693188 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |