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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126838361 | 12683836 | 1 | I | 20160728 | 20160825 | 20160825 | PER | US-009507513-1608USA000242 | MERCK | 0.00 | M | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126838361 | 12683836 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | 200 MG/M2/DAY, DAYS 1-5 EVERY 28-DAY CYCLE, 15 CYCLES | 21029 | CAPSULE | ||||||||||
| 126838361 | 12683836 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | 100 MG/M2/DAY, DAYS 10-14,EVERY 28-DAY CYCLE, 2 CYCLES | 21029 | CAPSULE | ||||||||||
| 126838361 | 12683836 | 3 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | 75 MG/M2/DAY | 21029 | CAPSULE | ||||||||||
| 126838361 | 12683836 | 4 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | UNK | 0 | |||||||||||
| 126838361 | 12683836 | 5 | C | CABERGOLINE. | CABERGOLINE | 1 | UNK | 0 | |||||||||||
| 126838361 | 12683836 | 6 | C | CAPECITABINE. | CAPECITABINE | 1 | 1000 MG, QAM, DAYS 1-14 EVERY 28-DAY CYCLE, 2 CYCLES | 0 | QD | ||||||||||
| 126838361 | 12683836 | 7 | C | CAPECITABINE. | CAPECITABINE | 1 | 1500 MG, QPM, DAYS 1-14 EVERY 28-DAY CYCLE, 2 CYCLES | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126838361 | 12683836 | 1 | Neoplasm recurrence |
| 126838361 | 12683836 | 2 | Metastases to lymph nodes |
| 126838361 | 12683836 | 4 | Hypercorticoidism |
| 126838361 | 12683836 | 5 | Hypercorticoidism |
| 126838361 | 12683836 | 6 | Neoplasm recurrence |
| 126838361 | 12683836 | 7 | Metastases to lymph nodes |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126838361 | 12683836 | Fatigue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |