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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126263191 | 12626319 | 1 | I | 20090805 | 20090831 | 20160805 | 20160805 | EXP | GB-ASTELLAS-2009002633 | ASTELLAS | 67.07 | YR | M | Y | 0.00000 | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126263191 | 12626319 | 1 | PS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | 36 | DF | 0 | 1 | DF | FORMULATION UNKNOWN | QD | |||||
| 126263191 | 12626319 | 2 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | 36 | DF | 0 | FORMULATION UNKNOWN | |||||||||
| 126263191 | 12626319 | 3 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | U | 0 | 2 | MG | FORMULATION UNKNOWN | QD | ||||||
| 126263191 | 12626319 | 4 | C | ZOPICLONE | ZOPICLONE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126263191 | 12626319 | 5 | C | MST | MORPHINE SULFATENALTREXONE HYDROCHLORIDE | 1 | Oral | U | 0 | 20 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126263191 | 12626319 | 6 | C | RANITIDINE. | RANITIDINE | 1 | Oral | U | 0 | 150 | MG | FORMULATION UNKNOWN | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126263191 | 12626319 | 1 | Non-small cell lung cancer |
| 126263191 | 12626319 | 2 | Metastases to central nervous system |
| 126263191 | 12626319 | 3 | Product used for unknown indication |
| 126263191 | 12626319 | 4 | Insomnia |
| 126263191 | 12626319 | 5 | Pain |
| 126263191 | 12626319 | 6 | Antacid therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126263191 | 12626319 | DE |
| 126263191 | 12626319 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126263191 | 12626319 | Dyspnoea |
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 |
|---|---|---|---|---|---|---|
| 126263191 | 12626319 | 1 | 20090701 | 20090808 | 0 | |
| 126263191 | 12626319 | 4 | 200907 | 0 | ||
| 126263191 | 12626319 | 6 | 200906 | 0 |