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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125404906 | 12540490 | 6 | F | 20151026 | 20160829 | 20160708 | 20160902 | EXP | CA-SA-2015SA172507 | AVENTIS | 30.00 | YR | A | F | Y | 95.50000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125404906 | 12540490 | 1 | PS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | F3005H23 | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 125404906 | 12540490 | 2 | SS | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 4F667 | 0 | 25 | MG | ||||||||
| 125404906 | 12540490 | 3 | SS | DIMENHYDRINATE. | DIMENHYDRINATE | 1 | Intravenous (not otherwise specified) | 3H034 | 0 | 25 | MG | ||||||||
| 125404906 | 12540490 | 4 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 7190315 | 0 | 1 | G | ||||||||
| 125404906 | 12540490 | 5 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | 0 | 200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125404906 | 12540490 | 1 | Relapsing-remitting multiple sclerosis |
| 125404906 | 12540490 | 2 | Rash |
| 125404906 | 12540490 | 3 | Nausea |
| 125404906 | 12540490 | 4 | Throat irritation |
| 125404906 | 12540490 | 5 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125404906 | 12540490 | LT |
| 125404906 | 12540490 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125404906 | 12540490 | Arthralgia | |
| 125404906 | 12540490 | Basedow's disease | |
| 125404906 | 12540490 | Bladder disorder | |
| 125404906 | 12540490 | Blood thyroid stimulating hormone decreased | |
| 125404906 | 12540490 | Condition aggravated | |
| 125404906 | 12540490 | Creatinine urine decreased | |
| 125404906 | 12540490 | Creatinine urine increased | |
| 125404906 | 12540490 | Dizziness | |
| 125404906 | 12540490 | Dysphonia | |
| 125404906 | 12540490 | Dyspnoea | |
| 125404906 | 12540490 | Fatigue | |
| 125404906 | 12540490 | Goitre | |
| 125404906 | 12540490 | Haemoglobin increased | |
| 125404906 | 12540490 | Haemoglobin urine present | |
| 125404906 | 12540490 | Headache | |
| 125404906 | 12540490 | Heart rate increased | |
| 125404906 | 12540490 | Hyperhidrosis | |
| 125404906 | 12540490 | Leukocyturia | |
| 125404906 | 12540490 | Lymphocyte count decreased | |
| 125404906 | 12540490 | Mean cell volume decreased | |
| 125404906 | 12540490 | Muscular weakness | |
| 125404906 | 12540490 | Myalgia | |
| 125404906 | 12540490 | Palpitations | |
| 125404906 | 12540490 | Papillary thyroid cancer | |
| 125404906 | 12540490 | Red blood cell count increased | |
| 125404906 | 12540490 | Red blood cells urine | |
| 125404906 | 12540490 | Throat irritation | |
| 125404906 | 12540490 | Thyroxine free increased | |
| 125404906 | 12540490 | Tremor | |
| 125404906 | 12540490 | Urine abnormality | |
| 125404906 | 12540490 | Weight increased | |
| 125404906 | 12540490 | White blood cells urine positive |
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 |
|---|---|---|---|---|---|---|
| 125404906 | 12540490 | 1 | 20151026 | 20151028 | 0 | |
| 125404906 | 12540490 | 2 | 20151026 | 20151026 | 0 | |
| 125404906 | 12540490 | 3 | 20151026 | 20151026 | 0 | |
| 125404906 | 12540490 | 4 | 20151026 | 20151026 | 0 | |
| 125404906 | 12540490 | 5 | 20151208 | 0 |