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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127994211 | 12799421 | 1 | I | 20160920 | 20160930 | 20160930 | EXP | ES-JNJFOC-20160925823 | JANSSEN | VALERA RUBIO M, LABRADOR AND?JAR N, RUBIO SALVADOR A, CHAC?N L?PEZ-MU?IZ J, D?AZ PANIAGUA L. PHARMACOLOGICAL APPROACH FOR THE MANAGEMENT OF ADRENOCORTICAL CARCINOMA: A CASE REPORT. EUROPEAN JOURNAL OF CLINICAL PHARMACY 2016;18/3:199-201. | 16.00 | YR | T | F | Y | 0.00000 | 20160930 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127994211 | 12799421 | 1 | SS | CAELYX | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | RECEIVED 8 CYCLES | U | 0 | 50 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 127994211 | 12799421 | 2 | SS | CAELYX | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | ON DAY 1 | U | 0 | 20 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 127994211 | 12799421 | 3 | PS | CAELYX | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | ON DAY 1 | U | 50718 | 50 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 127994211 | 12799421 | 4 | SS | KETOCONAZOLE. | KETOCONAZOLE | 1 | Unknown | N | 0 | 400 | MG | UNSPECIFIED | Q12H | ||||||
| 127994211 | 12799421 | 5 | SS | SORAFENIB | SORAFENIB | 1 | Unknown | 0 | 400 | MG | UNSPECIFIED | Q12H | |||||||
| 127994211 | 12799421 | 6 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 0 | 2000 | MG/M**2 | UNSPECIFIED | ||||||||
| 127994211 | 12799421 | 7 | SS | MESNA. | MESNA | 1 | Unknown | ON DAY 1-3 | 0 | 2000 | MG/M**2 | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 8 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | ON DAYS 1, 2, 3 EVERY 21 DAYS | 0 | UNSPECIFIED | |||||||||
| 127994211 | 12799421 | 9 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | ON DAY 1 | 0 | 50 | MG/M**2 | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 10 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 0 | 50 | MG/M**2 | UNSPECIFIED | ||||||||
| 127994211 | 12799421 | 11 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | ON DAY 1 | 0 | 100 | MG/M**2 | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 12 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Unknown | EVERY 15 DAYS IN A 21 DAY-CYCLE | D | 0 | 15 | MG/KG | UNSPECIFIED | ||||||
| 127994211 | 12799421 | 13 | C | MITOTANE | MITOTANE | 1 | Unknown | D | 0 | 500 | MG | UNSPECIFIED | Q12H | ||||||
| 127994211 | 12799421 | 14 | C | MITOTANE | MITOTANE | 1 | Unknown | D | 0 | 9 | G | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 15 | C | MITOTANE | MITOTANE | 1 | Unknown | D | 0 | 3 | G | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 16 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | D | 0 | 50 | MG | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 17 | C | PACLITAX NAB | PACLITAXEL | 1 | Unknown | D | 0 | 150 | MG/M**2 | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 18 | C | CAPECITABINE. | CAPECITABINE | 1 | Unknown | D | 0 | 800 | MG | UNSPECIFIED | |||||||
| 127994211 | 12799421 | 19 | C | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | D | 0 | 800 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127994211 | 12799421 | 1 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 2 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 3 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 4 | Hypercorticoidism |
| 127994211 | 12799421 | 5 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 6 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 7 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 8 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 9 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 10 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 11 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 12 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 13 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 14 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 15 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 16 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 17 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 18 | Adrenocortical carcinoma |
| 127994211 | 12799421 | 19 | Adrenocortical carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127994211 | 12799421 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127994211 | 12799421 | Cystitis haemorrhagic | |
| 127994211 | 12799421 | Gastroenteritis | |
| 127994211 | 12799421 | Mucosal inflammation | |
| 127994211 | 12799421 | Off label use | |
| 127994211 | 12799421 | Pneumonia | |
| 127994211 | 12799421 | Product use issue | |
| 127994211 | 12799421 | Pyrexia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127994211 | 12799421 | 1 | 200909 | 0 | ||
| 127994211 | 12799421 | 2 | 201012 | 0 | ||
| 127994211 | 12799421 | 3 | 201203 | 0 | ||
| 127994211 | 12799421 | 5 | 201010 | 0 | ||
| 127994211 | 12799421 | 6 | 201012 | 0 | ||
| 127994211 | 12799421 | 7 | 201012 | 0 | ||
| 127994211 | 12799421 | 9 | 201203 | 0 | ||
| 127994211 | 12799421 | 10 | 200909 | 0 | ||
| 127994211 | 12799421 | 12 | 201301 | 0 | ||
| 127994211 | 12799421 | 15 | 200908 | 0 | ||
| 127994211 | 12799421 | 17 | 201301 | 0 | ||
| 127994211 | 12799421 | 18 | 201206 | 0 | ||
| 127994211 | 12799421 | 19 | 201206 | 0 |