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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127768621 | 12776862 | 1 | I | 20160912 | 20160923 | 20160923 | EXP | ES-TEVA-694189ISR | TEVA | VALERA RUBIO M, LABRADOR ANDUJAR N, RUBIO SALVADOR AR, CHACON LOPEZ-MUNIZ JI, DIAZ PANIAGUA L. PHARMACOLOGICAL APPROACH FOR THE MANAGEMENT OF ADRENOCORTICAL CARCINOMA: A CASE REPORT. EUR-J-CLIN-PHAM 2016;18(3):199-201. | 16.00 | YR | F | Y | 0.00000 | 20160924 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127768621 | 12776862 | 1 | PS | DOXORUBICIN | DOXORUBICIN | 1 | Unknown | 50 MG/M2 ON DAY 1, EVERY 21 DAYS | NASK | 63097 | |||||||||
| 127768621 | 12776862 | 2 | SS | LIPOSOMAL DOXORUBICIN | DOXORUBICIN HYDROCHLORIDE | 1 | Other | 20 MG/M2 ON DAY 1, EVERY 21 DAYS | U | 0 | 20 | MG/M**2 | |||||||
| 127768621 | 12776862 | 3 | SS | LIPOSOMAL DOXORUBICIN | DOXORUBICIN HYDROCHLORIDE | 1 | Other | 50 MG/M2 ON DAY 1, EVERY 21 DAYS | U | 0 | 50 | MG/M**2 | |||||||
| 127768621 | 12776862 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 100 MG/M2 ON DAYS 1, 2 ,3, EVERY 21 DAYS | U | 0 | 100 | MG/M**2 | |||||||
| 127768621 | 12776862 | 5 | SS | CAPECITABINE. | CAPECITABINE | 1 | Unknown | 800 MG | U | 91649 | 800 | MG | |||||||
| 127768621 | 12776862 | 6 | SS | filgrastim | FILGRASTIM | 1 | Unknown | 300 MCG, 5 DAYS | U | NASK | 125294 | ||||||||
| 127768621 | 12776862 | 7 | SS | mitotane | MITOTANE | 1 | Unknown | 500 MG/12 HOUR; THE DOSE WAS CHANGED TO 7 G/DAY | 0 | ||||||||||
| 127768621 | 12776862 | 8 | SS | mitotane | MITOTANE | 1 | Unknown | 7 G/DAY; THE DOSE WAS REDUCED TO 3 G/DAY | 0 | ||||||||||
| 127768621 | 12776862 | 9 | SS | mitotane | MITOTANE | 1 | Unknown | 3 G/DAY | 0 | ||||||||||
| 127768621 | 12776862 | 10 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 50 MG/M2 ON DAY 1; EVERY 21 DAYS | 0 | ||||||||||
| 127768621 | 12776862 | 11 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 100 MG/M2 ON DAY 1; EVERY 21 DAYS | 0 | ||||||||||
| 127768621 | 12776862 | 12 | SS | sorafenib | SORAFENIB | 1 | Unknown | 800 MILLIGRAM DAILY; 400 MG/12HR | 0 | 400 | MG | BID | |||||||
| 127768621 | 12776862 | 13 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Unknown | 2000 MG/M2; EVERY 21 DAYS | U | 0 | 2000 | MG/M**2 | |||||||
| 127768621 | 12776862 | 14 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | U | 0 | 800 | MG/M**2 | ||||||||
| 127768621 | 12776862 | 15 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | 50 MILLIGRAM DAILY; 50 MG/DAY | U | 0 | |||||||||
| 127768621 | 12776862 | 16 | C | MESNA. | MESNA | 1 | Unknown | 2000 MG/M2 ON DAYS 1-3 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127768621 | 12776862 | 1 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 2 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 4 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 5 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 6 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 7 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 10 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 12 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 13 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 14 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 15 | Adrenocortical carcinoma |
| 127768621 | 12776862 | 16 | Adrenocortical carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127768621 | 12776862 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127768621 | 12776862 | Blood creatinine abnormal | |
| 127768621 | 12776862 | Cystitis haemorrhagic | |
| 127768621 | 12776862 | Dermatitis exfoliative | |
| 127768621 | 12776862 | Diarrhoea | |
| 127768621 | 12776862 | Gastroenteritis | |
| 127768621 | 12776862 | Hepatotoxicity | |
| 127768621 | 12776862 | Hyperadrenocorticism | |
| 127768621 | 12776862 | Hypercholesterolaemia | |
| 127768621 | 12776862 | Mucosal inflammation | |
| 127768621 | 12776862 | Pancytopenia | |
| 127768621 | 12776862 | 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 |
|---|---|---|---|---|---|---|
| 127768621 | 12776862 | 1 | 200909 | 0 | ||
| 127768621 | 12776862 | 2 | 201012 | 0 | ||
| 127768621 | 12776862 | 3 | 201203 | 0 | ||
| 127768621 | 12776862 | 5 | 201206 | 0 | ||
| 127768621 | 12776862 | 9 | 200908 | 0 | ||
| 127768621 | 12776862 | 10 | 200909 | 0 | ||
| 127768621 | 12776862 | 12 | 201010 | 0 | ||
| 127768621 | 12776862 | 13 | 201012 | 0 | ||
| 127768621 | 12776862 | 14 | 201206 | 0 | ||
| 127768621 | 12776862 | 15 | 200908 | 0 | ||
| 127768621 | 12776862 | 16 | 201012 | 0 |