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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1252882611 | 12528826 | 11 | F | 20160627 | 20160817 | 20160705 | 20160823 | EXP | IT-SA-2016SA123199 | AVENTIS | 28.00 | YR | A | F | Y | 0.00000 | 20160823 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1252882611 | 12528826 | 1 | PS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | Y | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 1252882611 | 12528826 | 2 | SS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | Y | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 1252882611 | 12528826 | 3 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 1000 | MG | |||||||
| 1252882611 | 12528826 | 4 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | QD | ||||||||
| 1252882611 | 12528826 | 5 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | QD | ||||||||
| 1252882611 | 12528826 | 6 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | QD | ||||||||
| 1252882611 | 12528826 | 7 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | QD | ||||||||
| 1252882611 | 12528826 | 8 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 200 MG, 1 C X 2/DAY | 0 | 400 | MG | QD | |||||||
| 1252882611 | 12528826 | 9 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 0 | 200 | MG | QD | ||||||||
| 1252882611 | 12528826 | 10 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 1252882611 | 12528826 | 11 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 1252882611 | 12528826 | 12 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | QD | ||||||||
| 1252882611 | 12528826 | 13 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1252882611 | 12528826 | 1 | Multiple sclerosis relapse |
| 1252882611 | 12528826 | 2 | Relapsing-remitting multiple sclerosis |
| 1252882611 | 12528826 | 3 | Premedication |
| 1252882611 | 12528826 | 4 | Premedication |
| 1252882611 | 12528826 | 5 | Prophylaxis |
| 1252882611 | 12528826 | 6 | Premedication |
| 1252882611 | 12528826 | 7 | Prophylaxis |
| 1252882611 | 12528826 | 8 | Prophylaxis |
| 1252882611 | 12528826 | 9 | Prophylaxis |
| 1252882611 | 12528826 | 10 | Prophylaxis |
| 1252882611 | 12528826 | 11 | Prophylaxis |
| 1252882611 | 12528826 | 12 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1252882611 | 12528826 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1252882611 | 12528826 | Asthenia | |
| 1252882611 | 12528826 | Dyspepsia | |
| 1252882611 | 12528826 | Electrocardiogram QT prolonged | |
| 1252882611 | 12528826 | Gingival pain | |
| 1252882611 | 12528826 | Headache | |
| 1252882611 | 12528826 | Hypokalaemia | |
| 1252882611 | 12528826 | Noninfective gingivitis | |
| 1252882611 | 12528826 | Pruritus | |
| 1252882611 | 12528826 | 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 |
|---|---|---|---|---|---|---|
| 1252882611 | 12528826 | 1 | 20160627 | 20160701 | 0 | |
| 1252882611 | 12528826 | 2 | 20160627 | 20160701 | 0 | |
| 1252882611 | 12528826 | 3 | 20160627 | 20160629 | 0 | |
| 1252882611 | 12528826 | 4 | 20160627 | 20160629 | 0 | |
| 1252882611 | 12528826 | 5 | 20160627 | 20160629 | 0 | |
| 1252882611 | 12528826 | 6 | 20160630 | 20160701 | 0 | |
| 1252882611 | 12528826 | 7 | 20160630 | 20160701 | 0 | |
| 1252882611 | 12528826 | 8 | 20160626 | 20160801 | 0 | |
| 1252882611 | 12528826 | 9 | 20160626 | 0 | ||
| 1252882611 | 12528826 | 10 | 20160626 | 20160701 | 0 | |
| 1252882611 | 12528826 | 11 | 20160626 | 20160701 | 0 | |
| 1252882611 | 12528826 | 12 | 20160627 | 20160701 | 0 | |
| 1252882611 | 12528826 | 13 | 20160626 | 20160702 | 0 |