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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127043101 | 12704310 | 1 | I | 20160824 | 20160831 | 20160831 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-55852BI | BOEHRINGER INGELHEIM | GENERALISED SEIZURES WITH LETHAL COMPLICATIONS: CASE REPORT. -- 2016 AUG 23;. | 76.00 | YR | F | Y | 0.00000 | 20160831 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127043101 | 12704310 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 220 MG | U | 22512 | 110 | MG | BID | ||||||
| 127043101 | 12704310 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 0 | 5 | MG | |||||||||
| 127043101 | 12704310 | 3 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 0 | 2.5 | MG | |||||||||
| 127043101 | 12704310 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 5 MG | U | 0 | 5 | MG | QD | ||||||
| 127043101 | 12704310 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 2.1429 MG | U | 0 | 15 | MG | /wk | ||||||
| 127043101 | 12704310 | 6 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | FORMULATION: EXTENDED RELEASE | U | 0 | 37.5 | MG | |||||||
| 127043101 | 12704310 | 7 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | FORMULATION: EXTENDED RELEASE | U | 0 | 75 | MG | |||||||
| 127043101 | 12704310 | 8 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 0 | 30 | MG | |||||||||
| 127043101 | 12704310 | 9 | C | DOXEPIN | DOXEPIN | 1 | Unknown | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127043101 | 12704310 | 1 | Deep vein thrombosis |
| 127043101 | 12704310 | 2 | Insomnia |
| 127043101 | 12704310 | 3 | Depressed mood |
| 127043101 | 12704310 | 4 | Rheumatoid arthritis |
| 127043101 | 12704310 | 5 | Rheumatoid arthritis |
| 127043101 | 12704310 | 6 | Antidepressant therapy |
| 127043101 | 12704310 | 8 | Sleep disorder |
| 127043101 | 12704310 | 9 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127043101 | 12704310 | OT |
| 127043101 | 12704310 | DE |
| 127043101 | 12704310 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127043101 | 12704310 | Circulatory collapse | |
| 127043101 | 12704310 | Femoral neck fracture | |
| 127043101 | 12704310 | General physical health deterioration | |
| 127043101 | 12704310 | Generalised tonic-clonic seizure | |
| 127043101 | 12704310 | Haematoma | |
| 127043101 | 12704310 | Iron deficiency anaemia | |
| 127043101 | 12704310 | Patella fracture | |
| 127043101 | 12704310 | Tibia fracture | |
| 127043101 | 12704310 | Ulna fracture |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |