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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127834661 | 12783466 | 1 | I | 20160722 | 20160913 | 20160927 | 20160927 | EXP | GB-AUROBINDO-AUR-APL-2016-11931 | AUROBINDO | 42.00 | YR | M | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127834661 | 12783466 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Oral | 22.5 MG, ONCE A DAY | Y | U | 202050 | 22.5 | MG | QD | |||||
| 127834661 | 12783466 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Oral | 20 MG, ONCE A DAY | Y | U | 202050 | 20 | MG | QD | |||||
| 127834661 | 12783466 | 3 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | 300 MG, ONCE A DAY | 5400 | MG | Y | U | 0 | 300 | MG | TABLET | QD | ||
| 127834661 | 12783466 | 4 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | 50 MG, UNK | 5400 | MG | Y | U | 0 | 50 | MG | TABLET | |||
| 127834661 | 12783466 | 5 | SS | CLOZARIL | CLOZAPINE | 1 | Oral | UNK | 5400 | MG | Y | U | 0 | TABLET | |||||
| 127834661 | 12783466 | 6 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 127834661 | 12783466 | 7 | C | EPILIM | VALPROATE SODIUM | 1 | Oral | 900 MG, TWO TIMES A DAY | U | 0 | 900 | MG | BID | ||||||
| 127834661 | 12783466 | 8 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 5 MG, ONCE A DAY | U | 0 | 5 | MG | QD | ||||||
| 127834661 | 12783466 | 9 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 80 MG, ONCE A DAY | U | 0 | 80 | MG | QD | ||||||
| 127834661 | 12783466 | 10 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 200 MG, ONCE A DAY | U | 0 | 200 | MG | QD | ||||||
| 127834661 | 12783466 | 11 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 500 MG, TWO TIMES A DAY | U | 0 | 500 | MG | BID | ||||||
| 127834661 | 12783466 | 12 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 500 MG, 3 TIMES A DAY | U | 0 | 500 | MG | TID | ||||||
| 127834661 | 12783466 | 13 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 150 MG, ONCE A DAY | U | 0 | 150 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127834661 | 12783466 | 1 | Psychotic disorder |
| 127834661 | 12783466 | 3 | Schizophrenia |
| 127834661 | 12783466 | 4 | Psychotic disorder |
| 127834661 | 12783466 | 6 | Product used for unknown indication |
| 127834661 | 12783466 | 7 | Epilepsy |
| 127834661 | 12783466 | 8 | Product used for unknown indication |
| 127834661 | 12783466 | 9 | Type 2 diabetes mellitus |
| 127834661 | 12783466 | 10 | Epilepsy |
| 127834661 | 12783466 | 11 | Epilepsy |
| 127834661 | 12783466 | 12 | Type 2 diabetes mellitus |
| 127834661 | 12783466 | 13 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127834661 | 12783466 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127834661 | 12783466 | Aphasia | |
| 127834661 | 12783466 | Blood calcium decreased | |
| 127834661 | 12783466 | Blood cholesterol decreased | |
| 127834661 | 12783466 | Confusional state | |
| 127834661 | 12783466 | Dyspnoea | |
| 127834661 | 12783466 | Dysstasia | |
| 127834661 | 12783466 | Fall | |
| 127834661 | 12783466 | Haematocrit decreased | |
| 127834661 | 12783466 | Haemoglobin decreased | |
| 127834661 | 12783466 | Lymphocyte count increased | |
| 127834661 | 12783466 | Malaise | |
| 127834661 | 12783466 | Mean cell volume increased | |
| 127834661 | 12783466 | Neutrophil count increased | |
| 127834661 | 12783466 | Pharyngitis | |
| 127834661 | 12783466 | Pyrexia | |
| 127834661 | 12783466 | Red blood cell count decreased | |
| 127834661 | 12783466 | Respiratory rate increased | |
| 127834661 | 12783466 | Seizure | |
| 127834661 | 12783466 | Somnolence | |
| 127834661 | 12783466 | 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 |
|---|---|---|---|---|---|---|
| 127834661 | 12783466 | 1 | 2008 | 0 | ||
| 127834661 | 12783466 | 3 | 20160704 | 0 | ||
| 127834661 | 12783466 | 5 | 20160723 | 0 |