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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118557124 | 11855712 | 4 | F | 2013 | 20160114 | 20151221 | 20160128 | PER | PHHY2015US152022 | SANDOZ | 0.00 | F | Y | 0.00000 | 20160128 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118557124 | 11855712 | 1 | SS | BACLOFEN INTRATHECAL | BACLOFEN | 1 | Intrathecal | 130.92 MCG/DAY | 0 | 130.92 | UG | AMPOULE | QD | ||||||
| 118557124 | 11855712 | 2 | SS | BACLOFEN INTRATHECAL | BACLOFEN | 1 | Intrathecal | MINIMUM RATE | 0 | AMPOULE | |||||||||
| 118557124 | 11855712 | 3 | SS | BACLOFEN. | BACLOFEN | 1 | Unknown | 0 | |||||||||||
| 118557124 | 11855712 | 4 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | 77713 | ||||||||||
| 118557124 | 11855712 | 5 | SS | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | |||||||||||
| 118557124 | 11855712 | 6 | SS | FERROUS SULFATE | FERROUS SULFATEFERROUS SULFATE, DRIED | 1 | Unknown | UNK | 0 | ||||||||||
| 118557124 | 11855712 | 7 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 118557124 | 11855712 | 8 | SS | OMNICEF | CEFDINIR | 1 | Unknown | UNK | 0 | ||||||||||
| 118557124 | 11855712 | 9 | SS | OXYBUTYNIN | OXYBUTYNIN | 1 | Unknown | 0 | |||||||||||
| 118557124 | 11855712 | 10 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | |||||||||||
| 118557124 | 11855712 | 11 | SS | CALCIUM | CALCIUM | 1 | Unknown | 0 | |||||||||||
| 118557124 | 11855712 | 12 | SS | POTASSIUM | POTASSIUM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118557124 | 11855712 | 1 | Muscle spasticity |
| 118557124 | 11855712 | 2 | Cerebral palsy |
| 118557124 | 11855712 | 3 | Product used for unknown indication |
| 118557124 | 11855712 | 4 | Product used for unknown indication |
| 118557124 | 11855712 | 5 | Product used for unknown indication |
| 118557124 | 11855712 | 6 | Product used for unknown indication |
| 118557124 | 11855712 | 7 | Product used for unknown indication |
| 118557124 | 11855712 | 8 | Product used for unknown indication |
| 118557124 | 11855712 | 9 | Product used for unknown indication |
| 118557124 | 11855712 | 10 | Product used for unknown indication |
| 118557124 | 11855712 | 11 | Product used for unknown indication |
| 118557124 | 11855712 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118557124 | 11855712 | Adverse drug reaction | |
| 118557124 | 11855712 | Back pain | |
| 118557124 | 11855712 | Dizziness | |
| 118557124 | 11855712 | Fatigue | |
| 118557124 | 11855712 | Hypoaesthesia | |
| 118557124 | 11855712 | Muscle tightness | |
| 118557124 | 11855712 | Night sweats | |
| 118557124 | 11855712 | Rash | |
| 118557124 | 11855712 | Therapeutic response 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 |
|---|---|---|---|---|---|---|
| 118557124 | 11855712 | 1 | 20110114 | 0 | ||
| 118557124 | 11855712 | 2 | 20151201 | 0 |