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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124509143 | 12450914 | 3 | F | 20150205 | 20160714 | 20160609 | 20160726 | EXP | US-BIOGEN-2015BI031256 | BIOGEN | 39.00 | YR | F | Y | 59.02000 | KG | 20160726 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124509143 | 12450914 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | |||||||
| 124509143 | 12450914 | 2 | C | AMPYRA | DALFAMPRIDINE | 1 | 22250 | UNKNOWN | |||||||||||
| 124509143 | 12450914 | 3 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | UNKNOWN | Q6H | |||||||
| 124509143 | 12450914 | 4 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | 10 | MG | TABLETS | TID | |||||||
| 124509143 | 12450914 | 5 | C | BISACODYL. | BISACODYL | 1 | Rectal | 0 | 10 | MG | UNKNOWN | QD | |||||||
| 124509143 | 12450914 | 6 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Oral | 0 | 10 | MG | UNKNOWN | QD | |||||||
| 124509143 | 12450914 | 7 | C | DETROL LA | TOLTERODINE TARTRATE | 1 | 0 | 2 | MG | TABLETS | QD | ||||||||
| 124509143 | 12450914 | 8 | C | DOCUSATE/SENNA | DOCUSATE SODIUMSENNA LEAF | 1 | Oral | 0 | TABLETS | QD | |||||||||
| 124509143 | 12450914 | 9 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | 0 | 20 | MG | TABLETS | QD | |||||||
| 124509143 | 12450914 | 10 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | 0 | 800 | MG | UNKNOWN | TID | |||||||
| 124509143 | 12450914 | 11 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Oral | 0 | 5 | MG | UNKNOWN | QD | |||||||
| 124509143 | 12450914 | 12 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | TABLETS | QD | |||||||||
| 124509143 | 12450914 | 13 | C | POLYETHYLENE GLYCOL | POLYETHYLENE GLYCOLS | 1 | Oral | 0 | UNKNOWN | QD | |||||||||
| 124509143 | 12450914 | 14 | C | RITUXAN | RITUXIMAB | 1 | 10831 | UNKNOWN | |||||||||||
| 124509143 | 12450914 | 15 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | 1000 | IU | UNKNOWN | QD | |||||||
| 124509143 | 12450914 | 16 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 0 | 4 | MG | TABLETS | Q6H | |||||||
| 124509143 | 12450914 | 17 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124509143 | 12450914 | 1 | Multiple sclerosis |
| 124509143 | 12450914 | 2 | Fatigue |
| 124509143 | 12450914 | 3 | Pain |
| 124509143 | 12450914 | 4 | Multiple sclerosis |
| 124509143 | 12450914 | 5 | Constipation |
| 124509143 | 12450914 | 6 | Muscle spasms |
| 124509143 | 12450914 | 8 | Constipation |
| 124509143 | 12450914 | 10 | Pain |
| 124509143 | 12450914 | 11 | Urinary incontinence |
| 124509143 | 12450914 | 13 | Constipation |
| 124509143 | 12450914 | 14 | Muscular weakness |
| 124509143 | 12450914 | 15 | Nutritional supplementation |
| 124509143 | 12450914 | 16 | Nausea |
| 124509143 | 12450914 | 17 | Vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124509143 | 12450914 | LT |
| 124509143 | 12450914 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124509143 | 12450914 | Fall | |
| 124509143 | 12450914 | Headache | |
| 124509143 | 12450914 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 124509143 | 12450914 | 1 | 20140108 | 20140508 | 0 | |
| 124509143 | 12450914 | 4 | 20130911 | 0 | ||
| 124509143 | 12450914 | 14 | 201405 | 0 | ||
| 124509143 | 12450914 | 15 | 20140113 | 0 |