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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127116791 | 12711679 | 1 | I | 20160217 | 20160822 | 20160902 | 20160902 | EXP | IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-122876 | RANBAXY | 63.65 | YR | F | Y | 60.00000 | KG | 20160902 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127116791 | 12711679 | 1 | PS | Temozolomide SUN 100 mg hard capsules | TEMOZOLOMIDE | 1 | Oral | 100 MG DAILY | U | U | 201742 | 100 | MG | CAPSULE, HARD | |||||
| 127116791 | 12711679 | 2 | SS | Temozolomide SUN 20 mg hard capsules | TEMOZOLOMIDE | 1 | Oral | 20 MG DAILY | U | U | 201742 | 20 | MG | CAPSULE, HARD | |||||
| 127116791 | 12711679 | 3 | SS | TEMOZOLOMIDE SUN 5 MG HARD CAPSULES | TEMOZOLOMIDE | 1 | Oral | 5 MG DAILY | U | U | 201742 | 5 | MG | CAPSULE, HARD | |||||
| 127116791 | 12711679 | 4 | SS | TEMODAL | TEMOZOLOMIDE | 1 | Oral | 250 MG DAILY | U | U | 0 | 250 | MG | ||||||
| 127116791 | 12711679 | 5 | C | ONDANSETRONE TEVA 8 MG | ONDANSETRON | 1 | Oral | U | U | 0 | |||||||||
| 127116791 | 12711679 | 6 | C | PLASIL | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | U | U | 0 | |||||||||
| 127116791 | 12711679 | 7 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Oral | U | U | 0 | |||||||||
| 127116791 | 12711679 | 8 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | U | U | 0 | |||||||||
| 127116791 | 12711679 | 9 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127116791 | 12711679 | 1 | Glioblastoma |
| 127116791 | 12711679 | 2 | Glioblastoma |
| 127116791 | 12711679 | 3 | Glioblastoma |
| 127116791 | 12711679 | 4 | Glioblastoma |
| 127116791 | 12711679 | 5 | Product used for unknown indication |
| 127116791 | 12711679 | 6 | Product used for unknown indication |
| 127116791 | 12711679 | 7 | Product used for unknown indication |
| 127116791 | 12711679 | 8 | Product used for unknown indication |
| 127116791 | 12711679 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127116791 | 12711679 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127116791 | 12711679 | Anaemia | |
| 127116791 | 12711679 | Balance disorder | |
| 127116791 | 12711679 | Confusional state | |
| 127116791 | 12711679 | Disorientation | |
| 127116791 | 12711679 | Neutropenia | |
| 127116791 | 12711679 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 127116791 | 12711679 | 4 | 20151218 | 20151222 | 0 |