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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126407731 | 12640773 | 1 | I | 20100516 | 20100525 | 20160810 | 20160810 | EXP | GB-ASTELLAS-2010002118 | ASTELLAS | 65.28 | YR | F | Y | 0.00000 | 20160810 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126407731 | 12640773 | 1 | PS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | UNK, ONCE DAILY | 0 | FORMULATION UNKNOWN | QD | ||||||||
| 126407731 | 12640773 | 2 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | 0 | FORMULATION UNKNOWN | |||||||||||
| 126407731 | 12640773 | 3 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | U | 0 | 6 | MG | FORMULATION UNKNOWN | QD | ||||||
| 126407731 | 12640773 | 4 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | U | 0 | 30 | MG | FORMULATION UNKNOWN | QD | ||||||
| 126407731 | 12640773 | 5 | C | EPILIM | VALPROATE SODIUM | 1 | Oral | U | 0 | 300 | MG | FORMULATION UNKNOWN | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126407731 | 12640773 | 1 | Non-small cell lung cancer |
| 126407731 | 12640773 | 2 | Metastases to central nervous system |
| 126407731 | 12640773 | 3 | Brain oedema |
| 126407731 | 12640773 | 4 | Prophylaxis against gastrointestinal ulcer |
| 126407731 | 12640773 | 5 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126407731 | 12640773 | OT |
| 126407731 | 12640773 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126407731 | 12640773 | Lung cancer metastatic | |
| 126407731 | 12640773 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 126407731 | 12640773 | 1 | 20100505 | 20100516 | 0 | |
| 126407731 | 12640773 | 3 | 201003 | 20100516 | 0 | |
| 126407731 | 12640773 | 4 | 201003 | 20100516 | 0 | |
| 126407731 | 12640773 | 5 | 201003 | 20100516 | 0 |