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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125317234 | 12531723 | 4 | F | 20160509 | 20160914 | 20160706 | 20160922 | EXP | CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-31146CN | BOEHRINGER INGELHEIM | 78.34 | YR | M | Y | 0.00000 | 20160922 | MD | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125317234 | 12531723 | 1 | PS | OFEV | NINTEDANIB | 1 | Oral | 300 MG | Y | 205832 | 150 | MG | CAPSULE | BID | |||||
| 125317234 | 12531723 | 2 | SS | OFEV | NINTEDANIB | 1 | Oral | 150 MG | Y | 205832 | 150 | MG | CAPSULE | QD | |||||
| 125317234 | 12531723 | 3 | SS | OFEV | NINTEDANIB | 1 | Oral | 200 MG | Y | 205832 | 100 | MG | CAPSULE | BID | |||||
| 125317234 | 12531723 | 4 | SS | OFEV | NINTEDANIB | 1 | Oral | 300 MG | Y | 205832 | 150 | MG | CAPSULE | BID | |||||
| 125317234 | 12531723 | 5 | SS | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | U | 0 | ||||||||||
| 125317234 | 12531723 | 6 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Unknown | U | 0 | ||||||||||
| 125317234 | 12531723 | 7 | SS | DILANTIN | PHENYTOIN | 1 | Unknown | U | 0 | ||||||||||
| 125317234 | 12531723 | 8 | C | LOPERAMIDE | LOPERAMIDE | 1 | Unknown | 0 | |||||||||||
| 125317234 | 12531723 | 9 | C | MORPHINE | MORPHINE | 1 | Unknown | 0 | |||||||||||
| 125317234 | 12531723 | 10 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125317234 | 12531723 | 1 | Idiopathic pulmonary fibrosis |
| 125317234 | 12531723 | 5 | Product used for unknown indication |
| 125317234 | 12531723 | 6 | Product used for unknown indication |
| 125317234 | 12531723 | 7 | Product used for unknown indication |
| 125317234 | 12531723 | 8 | Product used for unknown indication |
| 125317234 | 12531723 | 9 | Product used for unknown indication |
| 125317234 | 12531723 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125317234 | 12531723 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125317234 | 12531723 | Cerebrovascular accident | Cerebrovascular accident |
| 125317234 | 12531723 | Diarrhoea | |
| 125317234 | 12531723 | Drug interaction | |
| 125317234 | 12531723 | Fatigue | |
| 125317234 | 12531723 | Headache | Headache |
| 125317234 | 12531723 | Hyperacusis | |
| 125317234 | 12531723 | Hypertension | Hypertension |
| 125317234 | 12531723 | Neuralgia | |
| 125317234 | 12531723 | Tinnitus |
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 |
|---|---|---|---|---|---|---|
| 125317234 | 12531723 | 1 | 20160509 | 0 | ||
| 125317234 | 12531723 | 4 | 20160621 | 0 |