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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127153611 | 12715361 | 1 | I | 20160823 | 20160906 | 20160906 | EXP | US-CIPLA LTD.-2016US17856 | CIPLA | 0.00 | Y | 0.00000 | 20160906 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127153611 | 12715361 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 78759 | ||||||||
| 127153611 | 12715361 | 2 | SS | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 3 | SS | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | Unknown | UNK, 12 CYCLES | U | U | 0 | ||||||||
| 127153611 | 12715361 | 4 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 5 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC 6, ON DAY 1 | U | U | 0 | ||||||||
| 127153611 | 12715361 | 6 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 8 | SS | Doxorubicin | DOXORUBICIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 9 | SS | SORAFENIB | SORAFENIB | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 10 | SS | Vincristine | VINCRISTINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 11 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 127153611 | 12715361 | 12 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK, 12 CYCLES | U | U | 0 | ||||||||
| 127153611 | 12715361 | 13 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 2000 MG/M2 PER DOSE RUN OVER 1 HOUR EACH DAY, 3 DOSES OVER 3 DAYS | Y | U | 0 | 2000 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127153611 | 12715361 | 1 | Neuroblastoma |
| 127153611 | 12715361 | 2 | Neuroblastoma |
| 127153611 | 12715361 | 4 | Neuroblastoma |
| 127153611 | 12715361 | 6 | Neuroblastoma |
| 127153611 | 12715361 | 7 | Neuroblastoma |
| 127153611 | 12715361 | 8 | Neuroblastoma |
| 127153611 | 12715361 | 9 | Neuroblastoma |
| 127153611 | 12715361 | 10 | Neuroblastoma |
| 127153611 | 12715361 | 11 | Neuroblastoma |
| 127153611 | 12715361 | 13 | Neuroblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127153611 | 12715361 | HO |
| 127153611 | 12715361 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127153611 | 12715361 | Disease recurrence | |
| 127153611 | 12715361 | Encephalopathy | |
| 127153611 | 12715361 | Urinary tract obstruction |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |