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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126403741 | 12640374 | 1 | I | 20091011 | 20091020 | 20160810 | 20160810 | EXP | GB-ASTELLAS-2009003209 | ASTELLAS | 62.83 | YR | M | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126403741 | 12640374 | 1 | PS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | 1 DF, ONCE DAILY (LAST DOSE PRIOR TO SAE: 29 OCTOBER 2009) | 49 | DF | Y | 0 | 1 | DF | FORMULATION UNKNOWN | QD | |||
| 126403741 | 12640374 | 2 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | 49 | DF | 0 | FORMULATION UNKNOWN | |||||||||
| 126403741 | 12640374 | 3 | C | DICLOFENAC | DICLOFENAC | 1 | Oral | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126403741 | 12640374 | 4 | C | COCODAMOL | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126403741 | 12640374 | 5 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126403741 | 12640374 | 6 | C | NYSTATIN. | NYSTATIN | 1 | Topical | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126403741 | 12640374 | 1 | Non-small cell lung cancer |
| 126403741 | 12640374 | 2 | Metastases to central nervous system |
| 126403741 | 12640374 | 3 | Sciatica |
| 126403741 | 12640374 | 4 | Sciatica |
| 126403741 | 12640374 | 5 | Prophylaxis against gastrointestinal ulcer |
| 126403741 | 12640374 | 6 | Candida infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126403741 | 12640374 | DE |
| 126403741 | 12640374 | OT |
| 126403741 | 12640374 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126403741 | 12640374 | Back pain | |
| 126403741 | 12640374 | Malignant neoplasm progression | |
| 126403741 | 12640374 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 126403741 | 12640374 | 1 | 20090824 | 20091029 | 0 | |
| 126403741 | 12640374 | 3 | 20091007 | 0 | ||
| 126403741 | 12640374 | 4 | 20091007 | 0 | ||
| 126403741 | 12640374 | 5 | 20091007 | 0 | ||
| 126403741 | 12640374 | 6 | 20090921 | 20090928 | 0 |