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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125624611 | 12562461 | 1 | I | 20160303 | 20160609 | 20160715 | 20160715 | EXP | US-SAOL THERAPEUTICS-2016SAO00175 | SAOL THERAPEUTICS | 47.33 | YR | F | Y | 104.31000 | KG | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125624611 | 12562461 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 500 ?G, DAY | 411800 | UG | Y | 20075 | 500 | UG | INJECTION | QD | |||
| 125624611 | 12562461 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 550 ?G, DAY | 411800 | UG | Y | 20075 | 550 | UG | INJECTION | QD | |||
| 125624611 | 12562461 | 3 | SS | BACLOFEN. | BACLOFEN | 1 | 549.6 ?G, DAY | 411800 | UG | Y | 20075 | 549.6 | UG | INJECTION | QD | ||||
| 125624611 | 12562461 | 4 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 0.49 MG, DAY | Y | 0 | .49 | MG | QD | ||||||
| 125624611 | 12562461 | 5 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0.5 MG, 2X/DAY | 0 | .5 | MG | BID | ||||||||
| 125624611 | 12562461 | 6 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | 20 MG, 1X/DAY | 0 | 20 | MG | QD | ||||||||
| 125624611 | 12562461 | 7 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | 325 MG, 1X/DAY | 0 | 325 | MG | QD | ||||||||
| 125624611 | 12562461 | 8 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 1 DOSAGE UNITS, 2X/DAY | 0 | 1 | DF | BID | ||||||||
| 125624611 | 12562461 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | 1200 MG, 3X/DAY | 0 | 1200 | MG | TID | ||||||||
| 125624611 | 12562461 | 10 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 500 MG, 1X/DAY | 0 | 500 | MG | QD | ||||||||
| 125624611 | 12562461 | 11 | C | NITROFURANTOIN. | NITROFURANTOIN | 1 | 50 MG, 1X/DAY | 0 | 50 | MG | QD | ||||||||
| 125624611 | 12562461 | 12 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 40 MG, 1X/DAY | 0 | 40 | MG | QD | ||||||||
| 125624611 | 12562461 | 13 | C | WARFARIN | WARFARIN | 1 | 4 MG, 1X/DAY | 0 | 4 | MG | QD | ||||||||
| 125624611 | 12562461 | 14 | C | ALBUTEROL. | ALBUTEROL | 1 | 2 DOSAGE UNITS, AS NEEDED | 0 | 2 | DF | |||||||||
| 125624611 | 12562461 | 15 | C | BUPROPION. | BUPROPION | 1 | 150 MG, 1X/DAY | 0 | 150 | MG | QD | ||||||||
| 125624611 | 12562461 | 16 | C | TIZANIDINE. | TIZANIDINE | 1 | UNK MG, UNK | 0 | |||||||||||
| 125624611 | 12562461 | 17 | C | NASONEX | MOMETASONE FUROATE | 1 | 1 DOSAGE UNITS, AS NEEDED | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125624611 | 12562461 | 1 | Muscle spasticity |
| 125624611 | 12562461 | 4 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125624611 | 12562461 | DE |
| 125624611 | 12562461 | HO |
| 125624611 | 12562461 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125624611 | 12562461 | Acidosis | |
| 125624611 | 12562461 | Central pain syndrome | |
| 125624611 | 12562461 | Hyperkalaemia | |
| 125624611 | 12562461 | Hypothermia | |
| 125624611 | 12562461 | Hypoxic-ischaemic encephalopathy | |
| 125624611 | 12562461 | Muscle spasms | |
| 125624611 | 12562461 | Myoclonus | |
| 125624611 | 12562461 | Overdose | |
| 125624611 | 12562461 | Pain | |
| 125624611 | 12562461 | Respiratory failure | |
| 125624611 | 12562461 | Sepsis | |
| 125624611 | 12562461 | Septic shock | |
| 125624611 | 12562461 | Toxicity to various agents | |
| 125624611 | 12562461 | 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 |
|---|---|---|---|---|---|---|
| 125624611 | 12562461 | 1 | 20131203 | 20160216 | 0 | |
| 125624611 | 12562461 | 2 | 20160216 | 20160302 | 0 | |
| 125624611 | 12562461 | 3 | 20160302 | 0 | ||
| 125624611 | 12562461 | 4 | 20160302 | 0 |