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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126292373 | 12629237 | 3 | F | 20160726 | 20160829 | 20160808 | 20160909 | EXP | IT-TEVA-682012ACC | TEVA | 48.10 | YR | F | Y | 0.00000 | 20160909 | CN | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126292373 | 12629237 | 1 | PS | COPAXONE | GLATIRAMER ACETATE | 1 | 20 MILLIGRAM/MILLILITERS DAILY; | 928626 | 20622 | INJECTION | QD | ||||||||
| 126292373 | 12629237 | 2 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | |||||||||
| 126292373 | 12629237 | 3 | C | Laroxyl | AMITRIPTYLINE | 1 | Oral | 6 GTT DAILY; | 0 | 6 | GTT | QD | |||||||
| 126292373 | 12629237 | 4 | C | Ominc | 2 | Oral | 0 | ||||||||||||
| 126292373 | 12629237 | 5 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126292373 | 12629237 | 1 | Relapsing-remitting multiple sclerosis |
| 126292373 | 12629237 | 2 | Prophylaxis |
| 126292373 | 12629237 | 3 | Headache |
| 126292373 | 12629237 | 4 | Bladder disorder |
| 126292373 | 12629237 | 5 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126292373 | 12629237 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126292373 | 12629237 | Dyspnoea | |
| 126292373 | 12629237 | Feeling hot | |
| 126292373 | 12629237 | Injection site extravasation | |
| 126292373 | 12629237 | Palpitations |
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 |
|---|---|---|---|---|---|---|
| 126292373 | 12629237 | 1 | 20150414 | 0 | ||
| 126292373 | 12629237 | 4 | 20151220 | 0 |