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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124819243 | 12481924 | 3 | F | 20160404 | 20160818 | 20160620 | 20160826 | EXP | CA-SA-2016SA072814 | AVENTIS | 33.00 | YR | A | F | Y | 0.00000 | 20160826 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124819243 | 12481924 | 1 | PS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | F4002H26 | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 124819243 | 12481924 | 2 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 1 | G | |||||||
| 124819243 | 12481924 | 3 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | 25-50 MG; IV/PO | 0 | |||||||||||
| 124819243 | 12481924 | 4 | C | DIMENHYDRINATE. | DIMENHYDRINATE | 1 | IV/PO | 0 | 50 | MG | |||||||||
| 124819243 | 12481924 | 5 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 0 | 150 | MG | |||||||||
| 124819243 | 12481924 | 6 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 0 | 200 | MG | |||||||||
| 124819243 | 12481924 | 7 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 124819243 | 12481924 | 8 | C | REACTINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | |||||||||
| 124819243 | 12481924 | 9 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 0 | |||||||||||
| 124819243 | 12481924 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 0 | |||||||||||
| 124819243 | 12481924 | 11 | C | OXYBUTIN | OXYBUTYNIN | 1 | Oral | 0 | |||||||||||
| 124819243 | 12481924 | 12 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 0 | |||||||||||
| 124819243 | 12481924 | 13 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124819243 | 12481924 | 1 | Relapsing-remitting multiple sclerosis |
| 124819243 | 12481924 | 2 | Premedication |
| 124819243 | 12481924 | 3 | Premedication |
| 124819243 | 12481924 | 4 | Premedication |
| 124819243 | 12481924 | 5 | Premedication |
| 124819243 | 12481924 | 6 | Premedication |
| 124819243 | 12481924 | 7 | Premedication |
| 124819243 | 12481924 | 8 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124819243 | 12481924 | HO |
| 124819243 | 12481924 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124819243 | 12481924 | Abdominal pain upper | |
| 124819243 | 12481924 | Clostridium difficile infection | |
| 124819243 | 12481924 | Diarrhoea | |
| 124819243 | 12481924 | Dry mouth | |
| 124819243 | 12481924 | Dysgeusia | |
| 124819243 | 12481924 | Ear swelling | |
| 124819243 | 12481924 | Erythema | |
| 124819243 | 12481924 | Eye pain | |
| 124819243 | 12481924 | Fatigue | |
| 124819243 | 12481924 | Feeling hot | |
| 124819243 | 12481924 | Flushing | |
| 124819243 | 12481924 | Headache | |
| 124819243 | 12481924 | Hypoaesthesia oral | |
| 124819243 | 12481924 | Injection site pain | |
| 124819243 | 12481924 | Injection site swelling | |
| 124819243 | 12481924 | Lacrimation increased | |
| 124819243 | 12481924 | Nausea | |
| 124819243 | 12481924 | Optic neuritis | |
| 124819243 | 12481924 | Photosensitivity reaction | |
| 124819243 | 12481924 | Pruritus | |
| 124819243 | 12481924 | Pyelonephritis | |
| 124819243 | 12481924 | Pyrexia | |
| 124819243 | 12481924 | Rash | |
| 124819243 | 12481924 | Rash erythematous | |
| 124819243 | 12481924 | Rash macular | |
| 124819243 | 12481924 | Rash pruritic | |
| 124819243 | 12481924 | Rhinorrhoea | |
| 124819243 | 12481924 | Urosepsis | |
| 124819243 | 12481924 | Urticaria | |
| 124819243 | 12481924 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124819243 | 12481924 | 1 | 20160404 | 20160408 | 0 | |
| 124819243 | 12481924 | 2 | 20160404 | 20160406 | 0 | |
| 124819243 | 12481924 | 3 | 20160404 | 0 | ||
| 124819243 | 12481924 | 4 | 20160404 | 0 | ||
| 124819243 | 12481924 | 5 | 20160404 | 20160408 | 0 | |
| 124819243 | 12481924 | 6 | 20160404 | 0 | ||
| 124819243 | 12481924 | 7 | 20160404 | 0 | ||
| 124819243 | 12481924 | 8 | 20160404 | 20160408 | 0 |