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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127739631 | 12773963 | 1 | I | 20160630 | 20160908 | 20160923 | 20160923 | EXP | GB-AUROBINDO-AUR-APL-2016-11539 | AUROBINDO | 44.00 | YR | M | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127739631 | 12773963 | 1 | PS | Simvastatin film-coated tablets 40mg | SIMVASTATIN | 1 | Oral | 40 MG, UNK | 77691 | 40 | MG | TABLET | |||||||
| 127739631 | 12773963 | 2 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 127739631 | 12773963 | 3 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | 300 MG, QMO | 0 | 300 | MG | TABLET | |||||||
| 127739631 | 12773963 | 4 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | 500 MG, QMO | 0 | 500 | MG | TABLET | |||||||
| 127739631 | 12773963 | 5 | C | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 127739631 | 12773963 | 6 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Oral | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 127739631 | 12773963 | 7 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 30 MG, QD | U | 0 | 30 | MG | QD | ||||||
| 127739631 | 12773963 | 8 | C | PROCYCLIDINE | PROCYCLIDINE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 127739631 | 12773963 | 9 | C | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Oral | 200 MG, QD | U | 0 | 200 | MG | QD | ||||||
| 127739631 | 12773963 | 10 | C | THIAMINE. | THIAMINE | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 127739631 | 12773963 | 11 | C | ZOPICLONE | ZOPICLONE | 1 | Oral | 3.75 MG, QD | U | 0 | 3.75 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127739631 | 12773963 | 1 | Product used for unknown indication |
| 127739631 | 12773963 | 2 | Schizophrenia |
| 127739631 | 12773963 | 5 | Product used for unknown indication |
| 127739631 | 12773963 | 6 | Product used for unknown indication |
| 127739631 | 12773963 | 7 | Product used for unknown indication |
| 127739631 | 12773963 | 8 | Product used for unknown indication |
| 127739631 | 12773963 | 9 | Product used for unknown indication |
| 127739631 | 12773963 | 10 | Product used for unknown indication |
| 127739631 | 12773963 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127739631 | 12773963 | HO |
| 127739631 | 12773963 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127739631 | 12773963 | Blood creatine phosphokinase increased | |
| 127739631 | 12773963 | Psychotic disorder |
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 |
|---|---|---|---|---|---|---|
| 127739631 | 12773963 | 2 | 20100513 | 0 |