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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127210531 | 12721053 | 1 | I | 20160729 | 20160831 | 20160907 | 20160907 | EXP | FR-ROCHE-1824292 | ROCHE | 29.00 | YR | M | Y | 0.00000 | 20160907 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127210531 | 12721053 | 1 | PS | COTELLIC | COBIMETINIB | 1 | Oral | PRESCRIBED | 206192 | 20 | MG | ||||||||
| 127210531 | 12721053 | 2 | SS | COTELLIC | COBIMETINIB | 1 | Oral | ADMINISTERED | 206192 | 20 | MG | TABLET | BID | ||||||
| 127210531 | 12721053 | 3 | SS | COTELLIC | COBIMETINIB | 1 | Unknown | 206192 | 1 | DF | TABLET | ||||||||
| 127210531 | 12721053 | 4 | SS | COTELLIC | COBIMETINIB | 1 | Unknown | A DAY FOR 21 DAYS/48 | 206192 | 1 | DF | TABLET | |||||||
| 127210531 | 12721053 | 5 | SS | PREVISCAN (FRANCE) | FLUINDIONE | 1 | Oral | ALTERNATING 3/4/DAY 3/4/DAY 1/2/DAY | 0 | ||||||||||
| 127210531 | 12721053 | 6 | SS | PREVISCAN (FRANCE) | FLUINDIONE | 1 | Oral | (3/4) | 0 | ||||||||||
| 127210531 | 12721053 | 7 | SS | PREVISCAN (FRANCE) | FLUINDIONE | 1 | Oral | (3/4) | 0 | ||||||||||
| 127210531 | 12721053 | 8 | SS | PREVISCAN (FRANCE) | FLUINDIONE | 1 | Oral | (1/2) | 0 | ||||||||||
| 127210531 | 12721053 | 9 | SS | PREVISCAN (FRANCE) | FLUINDIONE | 1 | Oral | (1/2) AT 6:00 PM | 0 | ||||||||||
| 127210531 | 12721053 | 10 | SS | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | AT 6:00PM | 0 | 6000 | IU | BID | |||||||
| 127210531 | 12721053 | 11 | SS | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | AT 6:00 AM | 0 | 6000 | IU | ||||||||
| 127210531 | 12721053 | 12 | C | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Unknown | 180 MCG/WEEK | 0 | SOLUTION FOR INJECTION | |||||||||
| 127210531 | 12721053 | 13 | C | AERIUS | DESLORATADINE | 1 | Unknown | 0 | 1 | DF | TABLET | QD | |||||||
| 127210531 | 12721053 | 14 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | BETWEEN 1 G AND 3 G/DAY | 0 | ||||||||||
| 127210531 | 12721053 | 15 | C | VITAMIN K1 | PHYTONADIONE | 1 | Unknown | 1 AMPOULE?AT 01:25PM | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127210531 | 12721053 | 1 | Histiocytosis |
| 127210531 | 12721053 | 5 | Deep vein thrombosis |
| 127210531 | 12721053 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127210531 | 12721053 | HO |
| 127210531 | 12721053 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127210531 | 12721053 | Off label use | |
| 127210531 | 12721053 | Product use issue | |
| 127210531 | 12721053 | Pulmonary alveolar haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 127210531 | 12721053 | 1 | 20160726 | 0 | ||
| 127210531 | 12721053 | 2 | 20160729 | 0 | ||
| 127210531 | 12721053 | 3 | 20160730 | 0 | ||
| 127210531 | 12721053 | 5 | 2011 | 0 | ||
| 127210531 | 12721053 | 6 | 20160725 | 0 | ||
| 127210531 | 12721053 | 7 | 20160726 | 0 | ||
| 127210531 | 12721053 | 8 | 20160727 | 20160728 | 0 | |
| 127210531 | 12721053 | 9 | 20160729 | 0 | ||
| 127210531 | 12721053 | 10 | 20160729 | 0 | ||
| 127210531 | 12721053 | 11 | 20160730 | 0 | ||
| 127210531 | 12721053 | 15 | 20160728 | 0 |