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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126087211 | 12608721 | 1 | I | 20140416 | 20160711 | 20160729 | 20160729 | EXP | US-CONCORDIA PHARMACEUTICALS INC.-CO-PL-US-2016-383 | CONCORDIA | 71.29 | YR | F | Y | 65.50000 | KG | 20160729 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126087211 | 12608721 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | Y | 0 | 200 | MG | ||||||||
| 126087211 | 12608721 | 2 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Y | 0 | |||||||||||
| 126087211 | 12608721 | 3 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Y | 0 | |||||||||||
| 126087211 | 12608721 | 4 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Y | 0 | |||||||||||
| 126087211 | 12608721 | 5 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Y | 0 | |||||||||||
| 126087211 | 12608721 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 28 NG/KG/MIN | M362,P508,R271A,R614,S501,U631,Z606 | 0 | ||||||||||
| 126087211 | 12608721 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | M362,P508,R271A,R614,S501,U631,Z606 | 0 | |||||||||||
| 126087211 | 12608721 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | M362,P508,R271A,R614,S501,U631,Z606 | 0 | |||||||||||
| 126087211 | 12608721 | 9 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | QD | ||||||||
| 126087211 | 12608721 | 10 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 126087211 | 12608721 | 11 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 0 | 1000 | MG | BID | ||||||||
| 126087211 | 12608721 | 12 | C | BABY ASPIRIN | ASPIRIN | 1 | 0 | ||||||||||||
| 126087211 | 12608721 | 13 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | 0 | ||||||||||||
| 126087211 | 12608721 | 14 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126087211 | 12608721 | 15 | C | KENALOG | TRIAMCINOLONE ACETONIDE | 1 | 0 | ||||||||||||
| 126087211 | 12608721 | 16 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126087211 | 12608721 | 1 | Arthralgia |
| 126087211 | 12608721 | 2 | Pulmonary hypertension |
| 126087211 | 12608721 | 3 | Chorioretinopathy |
| 126087211 | 12608721 | 4 | Clostridium difficile colitis |
| 126087211 | 12608721 | 5 | Weight decreased |
| 126087211 | 12608721 | 6 | Cor pulmonale |
| 126087211 | 12608721 | 7 | Pulmonary hypertension |
| 126087211 | 12608721 | 8 | Polymyositis |
| 126087211 | 12608721 | 9 | Arthralgia |
| 126087211 | 12608721 | 12 | Product used for unknown indication |
| 126087211 | 12608721 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126087211 | 12608721 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126087211 | 12608721 | Catheterisation cardiac | |
| 126087211 | 12608721 | Diarrhoea | |
| 126087211 | 12608721 | Ejection fraction decreased | |
| 126087211 | 12608721 | Left ventricular dysfunction | |
| 126087211 | 12608721 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 126087211 | 12608721 | 6 | 20100222 | 0 |