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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127430521 | 12743052 | 1 | I | 2016 | 20160411 | 20160914 | 20160914 | PER | US-SIGMA-TAU US-2016STPI000281 | SIGMA TAU | 0.00 | M | Y | 0.00000 | 20160914 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127430521 | 12743052 | 1 | PS | MATULANE | PROCARBAZINE HYDROCHLORIDE | 1 | Oral | 150 MG, QD DAYS 8-21 | 16785 | 150 | MG | CAPSULE | QD | ||||||
| 127430521 | 12743052 | 2 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 2 MG, DAYS 8 AND 29 Q6W | U | 0 | 2 | MG | |||||||
| 127430521 | 12743052 | 3 | C | LOMUSTINE. | LOMUSTINE | 1 | 200 MG, Q6W ON DAY 1 | U | 0 | 200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127430521 | 12743052 | 1 | Anaplastic oligodendroglioma |
| 127430521 | 12743052 | 2 | Anaplastic oligodendroglioma |
| 127430521 | 12743052 | 3 | Anaplastic oligodendroglioma |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127430521 | 12743052 | Anaemia | |
| 127430521 | 12743052 | Hypersensitivity | |
| 127430521 | 12743052 | Neuropathy peripheral |
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 |
|---|---|---|---|---|---|---|
| 127430521 | 12743052 | 1 | 20160116 | 0 | ||
| 127430521 | 12743052 | 2 | 201601 | 0 | ||
| 127430521 | 12743052 | 3 | 201601 | 0 |