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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126556612 | 12655661 | 2 | F | 201607 | 20160823 | 20160816 | 20160907 | EXP | US-SAOL THERAPEUTICS-2016SAO00392 | SAOL THERAPEUTICS | 29.13 | YR | M | Y | 48.00000 | KG | 20160907 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126556612 | 12655661 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | U | U | 20075 | INJECTION | ||||||||
| 126556612 | 12655661 | 2 | SS | LIORESAL | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 126556612 | 12655661 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 4 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 5 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 6 | C | MULTIVITAMIN | VITAMINS | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 8 | C | SENNA | SENNA LEAFSENNOSIDESSENNOSIDES A AND B | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 9 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 10 | C | DANTROLENE SODIUM. | DANTROLENE SODIUM | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 11 | C | METOPROLOL. | METOPROLOL | 1 | 0 | ||||||||||||
| 126556612 | 12655661 | 12 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | TABLET | ||||||||||
| 126556612 | 12655661 | 13 | C | ENOXAPARIN SODIUM. | ENOXAPARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126556612 | 12655661 | 1 | Muscle spasticity |
| 126556612 | 12655661 | 2 | Cerebral palsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126556612 | 12655661 | HO |
| 126556612 | 12655661 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126556612 | 12655661 | Implant site infection | |
| 126556612 | 12655661 | Muscle spasticity | |
| 126556612 | 12655661 | Pseudomonas infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |