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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127290601 | 12729060 | 1 | I | 2015 | 20151130 | 20160909 | 20160909 | EXP | CA-SA-2015SA200480 | AVENTIS | 29.00 | YR | A | F | Y | 63.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127290601 | 12729060 | 1 | PS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | U | F4002H11 | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 127290601 | 12729060 | 2 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0091014 | 0 | 1 | G | QD | |||||||
| 127290601 | 12729060 | 3 | SS | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | UNKNOWN | 0 | 200 | MG | BID | |||||||
| 127290601 | 12729060 | 4 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | Q4-6 PRN | 836H | 0 | 1 | G | |||||||
| 127290601 | 12729060 | 5 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 0 | 150 | MG | BID | ||||||||
| 127290601 | 12729060 | 6 | C | DIMENHYDRINATE. | DIMENHYDRINATE | 1 | Intravenous (not otherwise specified) | Q4-6HR | DKK327401 | 0 | 50 | MG | QD | ||||||
| 127290601 | 12729060 | 7 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | Q4-6HR | 41121 | 0 | 50 | MG | QD | ||||||
| 127290601 | 12729060 | 8 | C | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 0 | 200 | MG | BID | ||||||||
| 127290601 | 12729060 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | |||||||||||
| 127290601 | 12729060 | 10 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 0 | |||||||||||
| 127290601 | 12729060 | 11 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127290601 | 12729060 | 1 | Relapsing-remitting multiple sclerosis |
| 127290601 | 12729060 | 2 | Premedication |
| 127290601 | 12729060 | 3 | Antiviral treatment |
| 127290601 | 12729060 | 4 | Premedication |
| 127290601 | 12729060 | 5 | Premedication |
| 127290601 | 12729060 | 6 | Premedication |
| 127290601 | 12729060 | 7 | Premedication |
| 127290601 | 12729060 | 8 | Antiviral treatment |
| 127290601 | 12729060 | 11 | Antidepressant therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127290601 | 12729060 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127290601 | 12729060 | Autoimmune thyroiditis | |
| 127290601 | 12729060 | Bacterial test | |
| 127290601 | 12729060 | Blood thyroid stimulating hormone decreased | |
| 127290601 | 12729060 | Feeling abnormal | |
| 127290601 | 12729060 | Headache | |
| 127290601 | 12729060 | Infusion site pain | |
| 127290601 | 12729060 | Insomnia | |
| 127290601 | 12729060 | Lymphocyte count decreased | |
| 127290601 | 12729060 | Lymphocyte percentage decreased | |
| 127290601 | 12729060 | Monocyte percentage increased | |
| 127290601 | 12729060 | Muscular weakness | |
| 127290601 | 12729060 | Neutrophil percentage increased | |
| 127290601 | 12729060 | Pain in extremity | |
| 127290601 | 12729060 | Specific gravity urine increased | |
| 127290601 | 12729060 | Tri-iodothyronine free increased | |
| 127290601 | 12729060 | Urinary sediment present | |
| 127290601 | 12729060 | Urine abnormality | |
| 127290601 | 12729060 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 127290601 | 12729060 | 1 | 20151130 | 20151203 | 0 | |
| 127290601 | 12729060 | 2 | 20151130 | 0 | ||
| 127290601 | 12729060 | 3 | 20151130 | 0 | ||
| 127290601 | 12729060 | 4 | 20151130 | 0 | ||
| 127290601 | 12729060 | 5 | 20151130 | 0 | ||
| 127290601 | 12729060 | 6 | 20151130 | 0 | ||
| 127290601 | 12729060 | 7 | 20151130 | 0 | ||
| 127290601 | 12729060 | 8 | 20151130 | 0 |