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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199222 | 12619922 | 2 | F | 20160324 | 20160818 | 20160803 | 20160902 | EXP | US-SAOL THERAPEUTICS-2016SAO00308 | SAOL THERAPEUTICS | 59.99 | YR | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199222 | 12619922 | 1 | PS | LIORESAL | BACLOFEN | 1 | 6 ?G PER HOUR | U | U | DS0084 | 0 | 6 | UG | INJECTION | |||||
| 126199222 | 12619922 | 2 | SS | LIORESAL | BACLOFEN | 1 | 1010 ?G, DAY | U | U | DS0084 | 0 | 1010 | UG | INJECTION | QD | ||||
| 126199222 | 12619922 | 3 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 20.3 ML, UP TO 4X/DAY | 0 | 20.3 | ML | ORAL SOLUTION | |||||||
| 126199222 | 12619922 | 4 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Oral | 20 MG, 1X/DAY | 0 | 20 | MG | TABLET | QD | ||||||
| 126199222 | 12619922 | 5 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Oral | 10 UNK, UNK | 0 | 10 | MG | TABLET | QD | ||||||
| 126199222 | 12619922 | 6 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 25 MG, 2X/DAY | 0 | 25 | MG | TABLET | BID | ||||||
| 126199222 | 12619922 | 7 | C | DIVALPROEX | DIVALPROEX SODIUM | 1 | 250 MG, 1X/DAY | 0 | 250 | MG | TABLET | QD | |||||||
| 126199222 | 12619922 | 8 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | 0 | CAPSULE | |||||||||||
| 126199222 | 12619922 | 9 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | 0 | ||||||||||||
| 126199222 | 12619922 | 10 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | 0 | NASAL SPRAY | |||||||||||
| 126199222 | 12619922 | 11 | C | HYPROMELLOSE | HYPROMELLOSES | 1 | 0 | EYE DROPS | |||||||||||
| 126199222 | 12619922 | 12 | C | GABAPENTIN. | GABAPENTIN | 1 | 300 MG, 3X/DAY | 0 | 300 | MG | CAPSULE | TID | |||||||
| 126199222 | 12619922 | 13 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 750 MG, 2X/DAY | 0 | 750 | MG | TABLET | BID | ||||||
| 126199222 | 12619922 | 14 | C | LORATADINE. | LORATADINE | 1 | Oral | 10 MG, 1X/DAY | 0 | 10 | MG | TABLET | QD | ||||||
| 126199222 | 12619922 | 15 | C | MAGNESIUM HYDOXIDE | 2 | 0 | ORAL SUSPENSION | ||||||||||||
| 126199222 | 12619922 | 16 | C | MULTIVITAMINS WITH MINERALS | MINERALSVITAMINS | 1 | 0 | TABLET | |||||||||||
| 126199222 | 12619922 | 17 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 8 MG, UP TO 3X/DAY | 0 | 8 | MG | TABLET | |||||||
| 126199222 | 12619922 | 18 | C | OXYCODONE-ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 126199222 | 12619922 | 19 | C | PRO-STAT SUGAR FREE 15-100 GRAM-KCAL 30ML LIQUID | 2 | 0 | |||||||||||||
| 126199222 | 12619922 | 20 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | Oral | 10 MG, UP TO 4X/DAY | 0 | 10 | MG | TABLET | |||||||
| 126199222 | 12619922 | 21 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 150 MG, 2X/DAY | 0 | 150 | MG | TABLET | BID | ||||||
| 126199222 | 12619922 | 22 | C | SIMETHICONE (DIMETHICONE) | DIMETHICONE | 1 | 0 | CHEWABLE TABLET | |||||||||||
| 126199222 | 12619922 | 23 | C | TIZANIDINE. | TIZANIDINE | 1 | 2 MG, 2X/DAY | 0 | 2 | MG | TABLET | BID | |||||||
| 126199222 | 12619922 | 24 | C | TIZANIDINE. | TIZANIDINE | 1 | 4 MG, 1X/DAY | 0 | 4 | MG | TABLET | QD | |||||||
| 126199222 | 12619922 | 25 | C | DAPTOMYCIN. | DAPTOMYCIN | 1 | Intravenous (not otherwise specified) | 320 MG, EVERY 48 HOURS | 0 | 320 | MG | QOD | |||||||
| 126199222 | 12619922 | 26 | SS | KEPPRA | LEVETIRACETAM | 1 | 750 MG 2X DAY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126199222 | 12619922 | 1 | Muscle spasticity |
| 126199222 | 12619922 | 2 | Spinal cord injury |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126199222 | 12619922 | HO |
| 126199222 | 12619922 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126199222 | 12619922 | Acute kidney injury | |
| 126199222 | 12619922 | Bladder cancer | |
| 126199222 | 12619922 | Confusional state | |
| 126199222 | 12619922 | Enterococcal infection | |
| 126199222 | 12619922 | Haemoglobin decreased | |
| 126199222 | 12619922 | Hyperkalaemia | |
| 126199222 | 12619922 | Hypertension | |
| 126199222 | 12619922 | Hypopnoea | |
| 126199222 | 12619922 | Seizure | |
| 126199222 | 12619922 | Sepsis | |
| 126199222 | 12619922 | Tachycardia | |
| 126199222 | 12619922 | Ureteric obstruction | |
| 126199222 | 12619922 | Urinary tract infection | |
| 126199222 | 12619922 | Urinary tract stoma complication | |
| 126199222 | 12619922 | Wound |
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 |
|---|---|---|---|---|---|---|
| 126199222 | 12619922 | 25 | 20160808 | 20160810 | 0 |