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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125515781 | 12551578 | 1 | I | 20160628 | 20160713 | 20160713 | EXP | US-CIPLA LTD.-2016US09457 | CIPLA | REARDON DA, VREDENBURGH JJ, COAN A, DESJARDINS A, PETERS KB, GURURANGAN S ET.AL. PHASE I STUDY OF SUNITINIB AND IRINOTECAN FOR PATIENTS WITH RECURRENT MALIGNANT GLIOMA. J NEUROONCOL. 2011;105:621 TO 627 | 0.00 | Y | 0.00000 | 20160713 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125515781 | 12551578 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK, PRIOR THERAPY | U | U | 77219 | ||||||||
| 125515781 | 12551578 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK, OVER 90 MIN ON DAYS 1, 15 AND 29 OF EACH 42 DAY CYCLE | U | U | 77219 | ||||||||
| 125515781 | 12551578 | 3 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | UNK | U | 0 | ||||||||||
| 125515781 | 12551578 | 4 | SS | Sunitinib | SUNITINIB | 1 | Oral | UNK, ONCE DAILY, 4 WEEKS FOLLOWED BY A 2 WEEK REST FOR EACH 42-DAY TREATMENT CYCLE | U | U | 0 | ||||||||
| 125515781 | 12551578 | 5 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | UNK, PRIOR THERAPY | U | U | 0 | ||||||||
| 125515781 | 12551578 | 6 | SS | VANDETANIB. | VANDETANIB | 1 | Unknown | UNK, PRIOR THERAPY | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125515781 | 12551578 | 1 | Malignant glioma |
| 125515781 | 12551578 | 3 | Malignant glioma |
| 125515781 | 12551578 | 4 | Malignant glioma |
| 125515781 | 12551578 | 5 | Malignant glioma |
| 125515781 | 12551578 | 6 | Malignant glioma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125515781 | 12551578 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125515781 | 12551578 | Amylase abnormal | |
| 125515781 | 12551578 | Disease progression | |
| 125515781 | 12551578 | Lipase abnormal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |