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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1148493615 | 11484936 | 15 | F | 2015 | 20160801 | 20150909 | 20160808 | EXP | CA-SA-2015SA116925 | AVENTIS | 38.00 | YR | A | F | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1148493615 | 11484936 | 1 | PS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | F3005H46 | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 1148493615 | 11484936 | 2 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 1 | G | |||||||
| 1148493615 | 11484936 | 3 | C | CHROME | 2 | Oral | 0 | ||||||||||||
| 1148493615 | 11484936 | 4 | C | FAMPYRA | DALFAMPRIDINE | 1 | Oral | 0 | |||||||||||
| 1148493615 | 11484936 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | |||||||||||
| 1148493615 | 11484936 | 6 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 0 | 200 | MG | |||||||||
| 1148493615 | 11484936 | 7 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 0 | 150 | MG | |||||||||
| 1148493615 | 11484936 | 8 | C | REACTINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1148493615 | 11484936 | 1 | Relapsing-remitting multiple sclerosis |
| 1148493615 | 11484936 | 2 | Premedication |
| 1148493615 | 11484936 | 4 | Multiple sclerosis |
| 1148493615 | 11484936 | 5 | Multiple sclerosis |
| 1148493615 | 11484936 | 6 | Premedication |
| 1148493615 | 11484936 | 7 | Premedication |
| 1148493615 | 11484936 | 8 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1148493615 | 11484936 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1148493615 | 11484936 | Abdominal discomfort | |
| 1148493615 | 11484936 | Abdominal pain | |
| 1148493615 | 11484936 | Back pain | |
| 1148493615 | 11484936 | Bacterial test | |
| 1148493615 | 11484936 | Blood urine present | |
| 1148493615 | 11484936 | Chills | |
| 1148493615 | 11484936 | Dyspepsia | |
| 1148493615 | 11484936 | Eructation | |
| 1148493615 | 11484936 | Erythema | |
| 1148493615 | 11484936 | Headache | |
| 1148493615 | 11484936 | Hyperthermia | |
| 1148493615 | 11484936 | Immunodeficiency | |
| 1148493615 | 11484936 | Lymphocyte count decreased | |
| 1148493615 | 11484936 | Lymphocyte percentage decreased | |
| 1148493615 | 11484936 | Nasopharyngitis | |
| 1148493615 | 11484936 | Nausea | |
| 1148493615 | 11484936 | Neck pain | |
| 1148493615 | 11484936 | Neutrophil percentage increased | |
| 1148493615 | 11484936 | Nitrite urine present | |
| 1148493615 | 11484936 | Poor quality sleep | |
| 1148493615 | 11484936 | Pruritus | |
| 1148493615 | 11484936 | Red blood cells urine positive | |
| 1148493615 | 11484936 | Specific gravity urine decreased | |
| 1148493615 | 11484936 | Urinary sediment present | |
| 1148493615 | 11484936 | Urinary tract infection | |
| 1148493615 | 11484936 | Urine analysis abnormal | |
| 1148493615 | 11484936 | Vaginal discharge | |
| 1148493615 | 11484936 | Vomiting | |
| 1148493615 | 11484936 | 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 |
|---|---|---|---|---|---|---|
| 1148493615 | 11484936 | 1 | 20150803 | 20150807 | 0 | |
| 1148493615 | 11484936 | 2 | 20150803 | 20150807 | 0 | |
| 1148493615 | 11484936 | 6 | 20150803 | 20150907 | 0 | |
| 1148493615 | 11484936 | 7 | 20150802 | 20150807 | 0 | |
| 1148493615 | 11484936 | 8 | 20150802 | 20150807 | 0 |