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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931871 | 12693187 | 1 | I | 20160818 | 20160829 | 20160829 | EXP | DE-MYLANLABS-2016M1035914 | MYLAN | KRUGER T, JOCKERS-SCHERUBL M, GROHMANN R, RUTHER E, DEGNER D. DEVELOPMENT OF EPILEPTIC SEIZURES UNDER THERAPY WITH OLANZAPINE AND VENLAFAXINE ER WITH FATAL OUTCOME. PSYCHOPHARMAKOTHERAPIE 2016;23(3):125-128. | 0.00 | Y | 0.00000 | 20160829 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931871 | 12693187 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 5 MG/ DAY | U | U | 202285 | ||||||||
| 126931871 | 12693187 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 2.5 MG/ DAY | U | U | 202285 | ||||||||
| 126931871 | 12693187 | 3 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 5 MG/ DAY | U | U | 202285 | ||||||||
| 126931871 | 12693187 | 4 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 2.5 MG/ DAY | U | U | 202285 | ||||||||
| 126931871 | 12693187 | 5 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | EXTENDED RELEASE 37.5 MG AND 75 MG | 112.5 | MG | U | U | 0 | ||||||
| 126931871 | 12693187 | 6 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 30 MG | U | 0 | |||||||||
| 126931871 | 12693187 | 7 | SS | DOXEPIN | DOXEPIN | 1 | Unknown | 25 MG | U | 0 | |||||||||
| 126931871 | 12693187 | 8 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 5 MG/ DAY | U | U | 0 | ||||||||
| 126931871 | 12693187 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 15 MG/ WEEK | U | U | 0 | ||||||||
| 126931871 | 12693187 | 10 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | AT ADMISSION | U | U | 0 | 110 | MG | BID | |||||
| 126931871 | 12693187 | 11 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 40 MG/DAY | U | U | 0 | ||||||||
| 126931871 | 12693187 | 12 | C | NALOXONE W/OXYCODONE | NALOXONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE | 1 | Unknown | 10/5 MG TWICE DAILY | U | 0 | |||||||||
| 126931871 | 12693187 | 13 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | LORAZEPAM (1 MG) 0.5 MG AND 0.25 MG | .75 | MG | U | U | 0 | ||||||
| 126931871 | 12693187 | 14 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0.5 MG X 2 | .75 | MG | U | U | 0 | ||||||
| 126931871 | 12693187 | 15 | C | FESOTERODINE | FESOTERODINE | 1 | Unknown | 8 MG/DAY | U | U | 0 | ||||||||
| 126931871 | 12693187 | 16 | C | CALCIUM | CALCIUM | 1 | Unknown | 500 MG/DAY | U | U | 0 | ||||||||
| 126931871 | 12693187 | 17 | C | COLECALCIFEROL | CHOLECALCIFEROL | 1 | Unknown | 1 X /WEEK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126931871 | 12693187 | 1 | Insomnia |
| 126931871 | 12693187 | 2 | Mood altered |
| 126931871 | 12693187 | 6 | Sleep disorder |
| 126931871 | 12693187 | 7 | Sleep disorder |
| 126931871 | 12693187 | 8 | Rheumatoid arthritis |
| 126931871 | 12693187 | 9 | Rheumatoid arthritis |
| 126931871 | 12693187 | 10 | Anticoagulant therapy |
| 126931871 | 12693187 | 12 | Pain |
| 126931871 | 12693187 | 13 | Anxiolytic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126931871 | 12693187 | HO |
| 126931871 | 12693187 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126931871 | 12693187 | Drug ineffective | |
| 126931871 | 12693187 | Dry mouth | |
| 126931871 | 12693187 | Generalised tonic-clonic seizure | |
| 126931871 | 12693187 | Haemorrhage | |
| 126931871 | 12693187 | Multiple fractures | |
| 126931871 | 12693187 | Osteoporosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |