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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118552725 | 11855272 | 5 | F | 20131208 | 20160907 | 20151221 | 20160914 | EXP | PHHY2013AT171568 | NOVARTIS | 53.00 | YR | M | Y | 98.00000 | KG | 20160914 | MD | AT | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118552725 | 11855272 | 1 | PS | VOTRIENT | PAZOPANIB HYDROCHLORIDE | 1 | Unknown | 800 MG, QD | 175200 | MG | 22465 | 800 | MG | TABLET | QD | ||||
| 118552725 | 11855272 | 2 | SS | VOTRIENT | PAZOPANIB HYDROCHLORIDE | 1 | Unknown | 400 MG, QD | 175200 | MG | 22465 | 400 | MG | TABLET | QD | ||||
| 118552725 | 11855272 | 3 | SS | VOTRIENT | PAZOPANIB HYDROCHLORIDE | 1 | Unknown | 400 MG, QD | 175200 | MG | 22465 | 400 | MG | TABLET | QD | ||||
| 118552725 | 11855272 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | Y | 0 | 10 | MG | QD | ||||||
| 118552725 | 11855272 | 5 | C | NEXAVAR | SORAFENIB | 1 | Unknown | UNK | 0 | ||||||||||
| 118552725 | 11855272 | 6 | C | NEXAVAR | SORAFENIB | 1 | ALTERNATIVELY AT 400/800 MG DOSE | 0 | |||||||||||
| 118552725 | 11855272 | 7 | C | PANTOLOC//PANTOPRAZOLE SODIUM SESQUIHYDRATE | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 118552725 | 11855272 | 8 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | 80 MG, QD | U | 0 | 80 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118552725 | 11855272 | 1 | Renal cell carcinoma |
| 118552725 | 11855272 | 4 | Renal cell carcinoma |
| 118552725 | 11855272 | 5 | Product used for unknown indication |
| 118552725 | 11855272 | 7 | Product used for unknown indication |
| 118552725 | 11855272 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118552725 | 11855272 | HO |
| 118552725 | 11855272 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118552725 | 11855272 | Anal fistula | |
| 118552725 | 11855272 | Body temperature increased | |
| 118552725 | 11855272 | Breath sounds | |
| 118552725 | 11855272 | Candida infection | |
| 118552725 | 11855272 | Cheilitis | |
| 118552725 | 11855272 | Cholelithiasis | |
| 118552725 | 11855272 | Diarrhoea | |
| 118552725 | 11855272 | Dyspnoea | |
| 118552725 | 11855272 | Hilar lymphadenopathy | |
| 118552725 | 11855272 | Laryngeal oedema | |
| 118552725 | 11855272 | Laryngitis | |
| 118552725 | 11855272 | Lip ulceration | |
| 118552725 | 11855272 | Malignant neoplasm progression | |
| 118552725 | 11855272 | Mucosal inflammation | |
| 118552725 | 11855272 | Necrotising fasciitis | |
| 118552725 | 11855272 | Neutropenia | |
| 118552725 | 11855272 | Night sweats | |
| 118552725 | 11855272 | Oedema mucosal | |
| 118552725 | 11855272 | Pain | |
| 118552725 | 11855272 | Pneumonia | |
| 118552725 | 11855272 | Productive cough | |
| 118552725 | 11855272 | Pubis fracture | |
| 118552725 | 11855272 | Renal failure | |
| 118552725 | 11855272 | Stomatitis | |
| 118552725 | 11855272 | Tongue ulceration |
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 |
|---|---|---|---|---|---|---|
| 118552725 | 11855272 | 1 | 20130324 | 20131028 | 0 | |
| 118552725 | 11855272 | 2 | 201311 | 20131212 | 0 | |
| 118552725 | 11855272 | 3 | 20140106 | 20140218 | 0 | |
| 118552725 | 11855272 | 4 | 20141216 | 0 | ||
| 118552725 | 11855272 | 5 | 201402 | 0 | ||
| 118552725 | 11855272 | 7 | 20131213 | 0 | ||
| 118552725 | 11855272 | 8 | 20131213 | 0 |