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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287162 | 12528716 | 2 | F | 2016 | 20160628 | 20160705 | 20160713 | EXP | US-SAOL THERAPEUTICS-2016SAO00024 | SAOL THERAPEUTICS | 0.00 | F | Y | 0.00000 | 20160713 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287162 | 12528716 | 1 | PS | LIORESAL | BACLOFEN | 1 | 630.6 ?G, DAY | U | U | DS0083 | 0 | 630.6 | UG | INJECTION | QD | ||||
| 125287162 | 12528716 | 2 | SS | ALBUTEROL. | ALBUTEROL | 1 | 0 | ||||||||||||
| 125287162 | 12528716 | 3 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 125287162 | 12528716 | 4 | SS | MYRBETRIQ | MIRABEGRON | 1 | 0 | ||||||||||||
| 125287162 | 12528716 | 5 | SS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | 600 MG, 3X/DAY | 0 | 600 | MG | TID | ||||||||
| 125287162 | 12528716 | 6 | SS | BACLOFEN (ORAL) | BACLOFEN | 1 | 20 MG, 4X/DAY | 0 | 20 | MG | QID | ||||||||
| 125287162 | 12528716 | 7 | SS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | 0 | |||||||||||
| 125287162 | 12528716 | 8 | SS | GABAPENTIN. | GABAPENTIN | 1 | 600 MG, 4X/DAY | 0 | 600 | MG | QID | ||||||||
| 125287162 | 12528716 | 9 | SS | NABUMETONE. | NABUMETONE | 1 | 750 MG, 2X/DAY | 0 | 750 | MG | BID | ||||||||
| 125287162 | 12528716 | 10 | SS | DIAZEPAM. | DIAZEPAM | 1 | 5 MG, 4X/DAY | 0 | 5 | MG | QID | ||||||||
| 125287162 | 12528716 | 11 | SS | OXYCODONE | OXYCODONE | 1 | UNK UNK, AS NEEDED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125287162 | 12528716 | 1 | Secondary progressive multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125287162 | 12528716 | OT |
| 125287162 | 12528716 | HO |
| 125287162 | 12528716 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125287162 | 12528716 | Acute respiratory failure | |
| 125287162 | 12528716 | Blood sodium decreased | |
| 125287162 | 12528716 | Encephalopathy | |
| 125287162 | 12528716 | Unresponsive to stimuli | |
| 125287162 | 12528716 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 125287162 | 12528716 | 1 | 20160602 | 0 |