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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1090415510 | 10904155 | 10 | F | 2015 | 20160818 | 20150311 | 20160826 | EXP | US-SA-2015SA019595 | AVENTIS | 52.00 | YR | A | F | Y | 0.00000 | 20160826 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1090415510 | 10904155 | 1 | PS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | U | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 1090415510 | 10904155 | 2 | SS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | U | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 1090415510 | 10904155 | 3 | SS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | U | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 1090415510 | 10904155 | 4 | SS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | U | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 1090415510 | 10904155 | 5 | SS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 1090415510 | 10904155 | 6 | SS | AMPYRA | DALFAMPRIDINE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 1090415510 | 10904155 | 7 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1090415510 | 10904155 | 1 | Multiple sclerosis relapse |
| 1090415510 | 10904155 | 2 | Multiple sclerosis relapse |
| 1090415510 | 10904155 | 3 | Multiple sclerosis relapse |
| 1090415510 | 10904155 | 4 | Multiple sclerosis relapse |
| 1090415510 | 10904155 | 5 | Multiple sclerosis relapse |
| 1090415510 | 10904155 | 7 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1090415510 | 10904155 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1090415510 | 10904155 | Asthenia | |
| 1090415510 | 10904155 | Burning sensation | |
| 1090415510 | 10904155 | Confusional state | |
| 1090415510 | 10904155 | Contusion | |
| 1090415510 | 10904155 | Dysphonia | |
| 1090415510 | 10904155 | Erythema | |
| 1090415510 | 10904155 | Eye infection | |
| 1090415510 | 10904155 | Fall | |
| 1090415510 | 10904155 | Fatigue | |
| 1090415510 | 10904155 | Feeling abnormal | |
| 1090415510 | 10904155 | Haematochezia | |
| 1090415510 | 10904155 | Headache | |
| 1090415510 | 10904155 | Hypersensitivity | |
| 1090415510 | 10904155 | Ill-defined disorder | |
| 1090415510 | 10904155 | Laceration | |
| 1090415510 | 10904155 | Malaise | |
| 1090415510 | 10904155 | Mass | |
| 1090415510 | 10904155 | Memory impairment | |
| 1090415510 | 10904155 | Migraine | |
| 1090415510 | 10904155 | Multiple sclerosis relapse | |
| 1090415510 | 10904155 | Neck pain | |
| 1090415510 | 10904155 | Oedema peripheral | |
| 1090415510 | 10904155 | Pain in extremity | |
| 1090415510 | 10904155 | Stomatitis | |
| 1090415510 | 10904155 | Upper limb fracture | |
| 1090415510 | 10904155 | Weight 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 |
|---|---|---|---|---|---|---|
| 1090415510 | 10904155 | 1 | 20150126 | 20150127 | 0 | |
| 1090415510 | 10904155 | 2 | 20150129 | 20150130 | 0 | |
| 1090415510 | 10904155 | 3 | 20160215 | 20160215 | 0 | |
| 1090415510 | 10904155 | 4 | 20150202 | 20150202 | 0 | |
| 1090415510 | 10904155 | 5 | 20160217 | 20160218 | 0 |