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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118801813 | 11880181 | 3 | F | 20151005 | 20160829 | 20151230 | 20160906 | EXP | GB-ABBVIE-15P-167-1529741-00 | ABBVIE | 54.00 | YR | F | Y | 0.00000 | 20160906 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118801813 | 11880181 | 1 | PS | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Oral | Y | UNKNOWN | 18081 | 1600 | MG | QD | ||||||
| 118801813 | 11880181 | 2 | SS | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Oral | Y | UNKNOWN | 18081 | 1800 | MG | QD | ||||||
| 118801813 | 11880181 | 3 | SS | AMISULPRIDE | AMISULPRIDE | 1 | Oral | Y | UNKNOWN | 0 | 200 | MG | |||||||
| 118801813 | 11880181 | 4 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | U | UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN | 0 | TABLET | ||||||||
| 118801813 | 11880181 | 5 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | U | UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN | 0 | 225 | MG | TABLET | ||||||
| 118801813 | 11880181 | 6 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | U | UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN | 0 | 175 | MG | TABLET | QD | |||||
| 118801813 | 11880181 | 7 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | U | UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN | 0 | 225 | MG | TABLET | QD | |||||
| 118801813 | 11880181 | 8 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | U | UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN | 0 | 150 | MG | TABLET | QD | |||||
| 118801813 | 11880181 | 9 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | U | UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN | 0 | 125 | MG | TABLET | QD | |||||
| 118801813 | 11880181 | 10 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | U | UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN | 0 | TABLET | ||||||||
| 118801813 | 11880181 | 11 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118801813 | 11880181 | 1 | Epilepsy |
| 118801813 | 11880181 | 3 | Schizophrenia |
| 118801813 | 11880181 | 4 | Schizophrenia |
| 118801813 | 11880181 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118801813 | 11880181 | OT |
| 118801813 | 11880181 | LT |
| 118801813 | 11880181 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118801813 | 11880181 | Blood creatinine decreased | |
| 118801813 | 11880181 | C-reactive protein increased | |
| 118801813 | 11880181 | Catatonia | |
| 118801813 | 11880181 | Cogwheel rigidity | |
| 118801813 | 11880181 | Coma | |
| 118801813 | 11880181 | Confusional state | |
| 118801813 | 11880181 | Fall | |
| 118801813 | 11880181 | Haemoglobin decreased | |
| 118801813 | 11880181 | Lethargy | |
| 118801813 | 11880181 | Loss of consciousness | |
| 118801813 | 11880181 | Neutrophil count increased | |
| 118801813 | 11880181 | Platelet count increased | |
| 118801813 | 11880181 | Pneumonia aspiration | |
| 118801813 | 11880181 | Sedation | |
| 118801813 | 11880181 | Sepsis | |
| 118801813 | 11880181 | Serotonin syndrome | |
| 118801813 | 11880181 | Somnolence | |
| 118801813 | 11880181 | Urinary tract infection | |
| 118801813 | 11880181 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 118801813 | 11880181 | 1 | 20150126 | 0 | ||
| 118801813 | 11880181 | 2 | 20151214 | 0 | ||
| 118801813 | 11880181 | 3 | 20140423 | 20151123 | 0 | |
| 118801813 | 11880181 | 4 | 20031104 | 0 | ||
| 118801813 | 11880181 | 5 | 20151109 | 0 | ||
| 118801813 | 11880181 | 6 | 20151123 | 0 | ||
| 118801813 | 11880181 | 10 | 20160824 | 0 | ||
| 118801813 | 11880181 | 11 | 20151109 | 0 |