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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126760291 | 12676029 | 1 | I | 20160801 | 20160823 | 20160823 | EXP | NL-AUROBINDO-AUR-APL-2016-10134 | AUROBINDO | MANENSCHIJN L, ET AL.. ORTERONEL/PREDNISONE: FATIGUE: CASE REPORT. REACTIONS WEEKLY. 2016;1612:146 | 73.00 | YR | M | Y | 0.00000 | 20160823 | OT | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126760291 | 12676029 | 1 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, TWO TIMES A DAY | Y | Y | 84774 | 5 | MG | BID | |||||
| 126760291 | 12676029 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, ONCE A DAY | Y | Y | 84774 | 5 | MG | QD | |||||
| 126760291 | 12676029 | 3 | SS | ORTERONEL | ORTERONEL | 1 | Unknown | 400 MG, TWO TIMES A DAY | Y | Y | 0 | 400 | MG | BID | |||||
| 126760291 | 12676029 | 4 | SS | ORTERONEL | ORTERONEL | 1 | Unknown | 200 UNK, UNK | Y | Y | 0 | 200 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126760291 | 12676029 | 1 | Product used for unknown indication |
| 126760291 | 12676029 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126760291 | 12676029 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126760291 | 12676029 | Fatigue | Fatigue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |