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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125519461 | 12551946 | 1 | I | 20140526 | 20160713 | 20160713 | EXP | CN-CIPLA LTD.-2014CN00508 | CIPLA | 0.00 | Y | 0.00000 | 20160713 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125519461 | 12551946 | 1 | PS | Irinotecan | IRINOTECAN | 1 | 50 MG/M2, QD, FOR 5 DAYS FOR 1 HOUR | U | U | 0 | 50 | MG/M**2 | INFUSION | ||||||
| 125519461 | 12551946 | 2 | SS | Vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 1.5 MG/M2, OVER 15 MIN, DAY 1, REPEATED EVERY 3 WEEKS | U | U | 0 | 1.5 | MG/M**2 | ||||||
| 125519461 | 12551946 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125519461 | 12551946 | 4 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125519461 | 12551946 | 5 | C | Granisetron | GRANISETRON | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125519461 | 12551946 | 6 | C | ATROPINE. | ATROPINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125519461 | 12551946 | 7 | C | Loperamide | LOPERAMIDE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125519461 | 12551946 | 1 | Hepatoblastoma recurrent |
| 125519461 | 12551946 | 2 | Hepatoblastoma recurrent |
| 125519461 | 12551946 | 3 | Hepatoblastoma |
| 125519461 | 12551946 | 4 | Premedication |
| 125519461 | 12551946 | 5 | Premedication |
| 125519461 | 12551946 | 6 | Prophylaxis against diarrhoea |
| 125519461 | 12551946 | 7 | Prophylaxis against diarrhoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125519461 | 12551946 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125519461 | 12551946 | Bone marrow failure | |
| 125519461 | 12551946 | Diarrhoea | |
| 125519461 | 12551946 | Disease recurrence | |
| 125519461 | 12551946 | Neutropenia | |
| 125519461 | 12551946 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |