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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80950933 | 8095093 | 3 | F | 201003 | 20121018 | 20110818 | 20121029 | EXP | US-BIOGENIDEC-2011BI030858 | BIOGEN | 64.00 | YR | F | Y | 0.00000 | 20121029 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80950933 | 8095093 | 1 | PS | TYSABRI | 1 | INTRAVENOUS | D | 125104 | 300 | MG | Intravenous infusion | /month | |||||||
| 80950933 | 8095093 | 2 | SS | TYSABRI | 1 | INTRAVENOUS | D | 125104 | 300 | MG | Intravenous infusion | /month | |||||||
| 80950933 | 8095093 | 3 | SS | TYSABRI | 1 | INTRAVENOUS | D | 125104 | 300 | MG | Intravenous infusion | /month | |||||||
| 80950933 | 8095093 | 4 | SS | TYSABRI | 1 | INTRAVENOUS | D | 125104 | 300 | MG | Intravenous infusion | /month | |||||||
| 80950933 | 8095093 | 5 | SS | TYSABRI | 1 | INTRAVENOUS | D | 125104 | 300 | MG | Intravenous infusion | /month | |||||||
| 80950933 | 8095093 | 6 | C | AMANTIDINE | 1 | ORAL | D | 0 | 100 | MG | BID | ||||||||
| 80950933 | 8095093 | 7 | C | BACLOFEN | 1 | ORAL | D | 0 | 20 | MG | TID | ||||||||
| 80950933 | 8095093 | 8 | C | VITAMIN D | 1 | ORAL | D | 0 | 400 | IU | BID | ||||||||
| 80950933 | 8095093 | 9 | C | SIMVASTATIN | 1 | ORAL | D | 0 | 20 | MG | BID | ||||||||
| 80950933 | 8095093 | 10 | C | SENNA | 1 | D | 0 | BID | |||||||||||
| 80950933 | 8095093 | 11 | C | CLEARLAX | 1 | D | 0 | ||||||||||||
| 80950933 | 8095093 | 12 | C | OXYBUTYNIN | 1 | ORAL | D | 0 | 5 | MG | |||||||||
| 80950933 | 8095093 | 13 | C | NYSTATIN POWDER | 2 | D | 0 | ||||||||||||
| 80950933 | 8095093 | 14 | C | NORTRIPTYLINE | 1 | ORAL | D | 0 | 10 | MG | BID | ||||||||
| 80950933 | 8095093 | 15 | C | NITROGLYCERINE | 1 | D | 0 | ||||||||||||
| 80950933 | 8095093 | 16 | C | METOPROLOL | 1 | ORAL | D | 0 | 25 | MG | QD | ||||||||
| 80950933 | 8095093 | 17 | C | METHOCARBAMOL | 1 | ORAL | D | 0 | 750 | MG | BID | ||||||||
| 80950933 | 8095093 | 18 | C | METFORMIN | 1 | ORAL | D | 0 | 500 | MG | BID | ||||||||
| 80950933 | 8095093 | 19 | C | LOSARTAN | 1 | ORAL | D | 0 | 25 | MG | QD | ||||||||
| 80950933 | 8095093 | 20 | C | LEVOTHYROXINE | 1 | ORAL | D | 0 | 0 | MG | QD | ||||||||
| 80950933 | 8095093 | 21 | C | FERROUS SULFATE | 1 | ORAL | D | 0 | 325 | MG | BID | ||||||||
| 80950933 | 8095093 | 22 | C | DOCUSATE SODIUM | 1 | D | 0 | ||||||||||||
| 80950933 | 8095093 | 23 | C | DIPHENHYDRAMINE | 1 | ORAL | D | 0 | 25 | MG | |||||||||
| 80950933 | 8095093 | 24 | C | CITALOPRAM | 1 | ORAL | D | 0 | 20 | MG | QD | ||||||||
| 80950933 | 8095093 | 25 | C | ACETAMINOPHEN | 1 | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 80950933 | 8095093 | 1 | Multiple sclerosis |
| 80950933 | 8095093 | 2 | Multiple sclerosis |
| 80950933 | 8095093 | 3 | Multiple sclerosis |
| 80950933 | 8095093 | 4 | Multiple sclerosis |
| 80950933 | 8095093 | 5 | Multiple sclerosis |
| 80950933 | 8095093 | 6 | Fatigue |
| 80950933 | 8095093 | 7 | Muscle spasticity |
| 80950933 | 8095093 | 10 | Constipation |
| 80950933 | 8095093 | 11 | Constipation |
| 80950933 | 8095093 | 12 | Urinary incontinence |
| 80950933 | 8095093 | 16 | Hypertension |
| 80950933 | 8095093 | 17 | Muscle spasms |
| 80950933 | 8095093 | 18 | Diabetes mellitus |
| 80950933 | 8095093 | 20 | Hypothyroidism |
| 80950933 | 8095093 | 21 | Anaemia |
| 80950933 | 8095093 | 22 | Constipation |
| 80950933 | 8095093 | 23 | Pruritus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 80950933 | 8095093 | OT |
| 80950933 | 8095093 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 80950933 | 8095093 | Acute myocardial infarction | |
| 80950933 | 8095093 | Convulsion |
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 |
|---|---|---|---|---|---|---|
| 80950933 | 8095093 | 1 | 20080111 | 20080307 | 0 | |
| 80950933 | 8095093 | 2 | 20090515 | 20090612 | 0 | |
| 80950933 | 8095093 | 3 | 20100106 | 20110928 | 0 | |
| 80950933 | 8095093 | 4 | 20120114 | 20120229 | 0 | |
| 80950933 | 8095093 | 5 | 20120625 | 20120723 | 0 |