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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122530492 | 12253049 | 2 | F | 20120209 | 20130819 | 20160411 | 20160818 | PER | PHEH2012US004203 | NOVARTIS | 24.23 | YR | F | Y | 62.13000 | KG | 20160818 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122530492 | 12253049 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 161.994003 | MG | N | 22527 | .5 | MG | CAPSULE | QD | |||
| 122530492 | 12253049 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 161.994003 | MG | N | 22527 | .5 | MG | CAPSULE | QD | |||
| 122530492 | 12253049 | 3 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | 1000 MG, BID | N | 0 | 1000 | MG | BID | ||||||
| 122530492 | 12253049 | 4 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | U | 0 | ||||||||||
| 122530492 | 12253049 | 5 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | N | 0 | ||||||||||
| 122530492 | 12253049 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | N | 0 | ||||||||||
| 122530492 | 12253049 | 7 | C | ADIPEX-P | PHENTERMINE HYDROCHLORIDE | 1 | Oral | N | 0 | ||||||||||
| 122530492 | 12253049 | 8 | C | ATIVAN | LORAZEPAM | 1 | Oral | N | 0 | ||||||||||
| 122530492 | 12253049 | 9 | C | DOXYCLINE ^KALBE FARMA^ | 2 | Oral | N | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122530492 | 12253049 | 1 | Multiple sclerosis |
| 122530492 | 12253049 | 3 | Product used for unknown indication |
| 122530492 | 12253049 | 4 | Product used for unknown indication |
| 122530492 | 12253049 | 5 | Product used for unknown indication |
| 122530492 | 12253049 | 6 | Product used for unknown indication |
| 122530492 | 12253049 | 7 | Product used for unknown indication |
| 122530492 | 12253049 | 8 | Product used for unknown indication |
| 122530492 | 12253049 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122530492 | 12253049 | Blood pressure decreased | |
| 122530492 | 12253049 | Heart rate decreased | |
| 122530492 | 12253049 | Maternal exposure during pregnancy |
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 |
|---|---|---|---|---|---|---|
| 122530492 | 12253049 | 1 | 20110324 | 20110609 | 0 | |
| 122530492 | 12253049 | 2 | 20110610 | 20120305 | 0 | |
| 122530492 | 12253049 | 3 | 201201 | 0 | ||
| 122530492 | 12253049 | 5 | 201202 | 0 | ||
| 122530492 | 12253049 | 6 | 201202 | 0 | ||
| 122530492 | 12253049 | 7 | 201201 | 0 | ||
| 122530492 | 12253049 | 8 | 201201 | 0 | ||
| 122530492 | 12253049 | 9 | 201202 | 0 |