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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124539254 | 12453925 | 4 | F | 20160520 | 20160915 | 20160609 | 20160927 | EXP | JP-UCBSA-2016020149 | UCB | 86.36 | YR | M | Y | 0.00000 | 20160927 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124539254 | 12453925 | 1 | PS | E Keppra | LEVETIRACETAM | 1 | Oral | 1000 MG, ONCE DAILY (QD) | 12000 | MG | Y | 21035 | 1000 | MG | FILM-COATED TABLET | QD | |||
| 124539254 | 12453925 | 2 | SS | ROCEPHIN | CEFTRIAXONE SODIUM | 1 | Intravenous (not otherwise specified) | DAILY DOSE:1 GM | Y | U | 0 | INJECTION | |||||||
| 124539254 | 12453925 | 3 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 50 MG, ONCE DAILY (QD) | U | 0 | 50 | MG | QD | ||||||
| 124539254 | 12453925 | 4 | C | AMITIZA | LUBIPROSTONE | 1 | Oral | 48 ?G, ONCE DAILY (QD) | U | 0 | 48 | UG | CAPSULE | QD | |||||
| 124539254 | 12453925 | 5 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, ONCE DAILY (QD) | U | 0 | 20 | MG | CAPSULE | QD | |||||
| 124539254 | 12453925 | 6 | C | FORTEO | TERIPARATIDE | 1 | 4 ?G, ONCE DAILY (QD) | 344 | UG | U | 0 | 4 | UG | QD | |||||
| 124539254 | 12453925 | 7 | C | Sulbactam sodium | SULBACTAM SODIUM | 1 | UNK, 3 G | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124539254 | 12453925 | 1 | Epilepsy |
| 124539254 | 12453925 | 2 | Urinary tract infection |
| 124539254 | 12453925 | 3 | Product used for unknown indication |
| 124539254 | 12453925 | 4 | Product used for unknown indication |
| 124539254 | 12453925 | 5 | Product used for unknown indication |
| 124539254 | 12453925 | 6 | Product used for unknown indication |
| 124539254 | 12453925 | 7 | Pneumonia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124539254 | 12453925 | HO |
| 124539254 | 12453925 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124539254 | 12453925 | Hepatic function abnormal | |
| 124539254 | 12453925 | Hepatomegaly | |
| 124539254 | 12453925 | Pneumonia | |
| 124539254 | 12453925 | Rib fracture |
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 |
|---|---|---|---|---|---|---|
| 124539254 | 12453925 | 1 | 20160513 | 20160524 | 0 | |
| 124539254 | 12453925 | 2 | 20160519 | 20160523 | 0 | |
| 124539254 | 12453925 | 3 | 20160229 | 0 | ||
| 124539254 | 12453925 | 4 | 20160229 | 0 | ||
| 124539254 | 12453925 | 5 | 20160229 | 0 | ||
| 124539254 | 12453925 | 6 | 20160229 | 20160527 | 0 | |
| 124539254 | 12453925 | 7 | 20160523 | 20160531 | 0 |