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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127223652 | 12722365 | 2 | F | 201603 | 20160909 | 20160907 | 20160923 | EXP | US-SAOL THERAPEUTICS-2016SAO00560 | SAOL THERAPEUTICS | 38.93 | YR | M | Y | 62.00000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127223652 | 12722365 | 1 | PS | LIORESAL | BACLOFEN | 1 | UNK | U | 20075 | INJECTION | |||||||||
| 127223652 | 12722365 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 195.06 ?G, DAY | 20075 | 195.6 | UG | INJECTION | QD | ||||||
| 127223652 | 12722365 | 3 | SS | LIORESAL | BACLOFEN | 1 | 20075 | INJECTION | |||||||||||
| 127223652 | 12722365 | 4 | SS | LIORESAL | BACLOFEN | 1 | UNK | Y | 20075 | INJECTION | |||||||||
| 127223652 | 12722365 | 5 | SS | LIORESAL | BACLOFEN | 1 | 169.9 ?G, DAY | Y | 20075 | 169.9 | UG | INJECTION | QD | ||||||
| 127223652 | 12722365 | 6 | SS | LIORESAL | BACLOFEN | 1 | 215.1 ?G, DAY | Y | 20075 | 215.1 | UG | INJECTION | QD | ||||||
| 127223652 | 12722365 | 7 | SS | LIORESAL | BACLOFEN | 1 | 119.9 ?G, DAY | Y | 20075 | 119.9 | UG | INJECTION | QD | ||||||
| 127223652 | 12722365 | 8 | SS | LIORESAL | BACLOFEN | 1 | 85.0 ?G, DAY | Y | 2158-103A | 20075 | 85 | UG | INJECTION | QD | |||||
| 127223652 | 12722365 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 2.5 MG, 1X/DAY | 0 | 2.5 | MG | QD | ||||||||
| 127223652 | 12722365 | 10 | C | DOCUSATE | DOCUSATE | 1 | 0 | ||||||||||||
| 127223652 | 12722365 | 11 | C | SCOPOLAMINE PATCH | SCOPOLAMINE | 1 | 0 | ||||||||||||
| 127223652 | 12722365 | 12 | C | TAMSULOSIN | TAMSULOSIN | 1 | 0.4 MG, 1X/DAY | 0 | .4 | MG | QD | ||||||||
| 127223652 | 12722365 | 13 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127223652 | 12722365 | 2 | Cerebral palsy |
| 127223652 | 12722365 | 3 | Muscle spasticity |
| 127223652 | 12722365 | 4 | Cerebral palsy |
| 127223652 | 12722365 | 5 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127223652 | 12722365 | OT |
| 127223652 | 12722365 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127223652 | 12722365 | Blood pressure decreased | |
| 127223652 | 12722365 | Constipation | |
| 127223652 | 12722365 | Device failure | |
| 127223652 | 12722365 | Device infusion issue | |
| 127223652 | 12722365 | Device issue | |
| 127223652 | 12722365 | Feeling abnormal | |
| 127223652 | 12722365 | Hiatus hernia | |
| 127223652 | 12722365 | Hyperhidrosis | |
| 127223652 | 12722365 | Oesophageal ulcer haemorrhage | |
| 127223652 | 12722365 | Pallor | |
| 127223652 | 12722365 | Somnolence | |
| 127223652 | 12722365 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 127223652 | 12722365 | 1 | 201109 | 0 | ||
| 127223652 | 12722365 | 2 | 201602 | 0 | ||
| 127223652 | 12722365 | 4 | 20160809 | 20160817 | 0 | |
| 127223652 | 12722365 | 5 | 20160817 | 20160824 | 0 | |
| 127223652 | 12722365 | 6 | 20160824 | 20160831 | 0 | |
| 127223652 | 12722365 | 7 | 20160831 | 20160907 | 0 | |
| 127223652 | 12722365 | 8 | 20160907 | 0 |