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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1158911520 | 11589115 | 20 | F | 2015 | 20160705 | 20151002 | 20160708 | PER | US-PFIZER INC-2015316316 | PFIZER | 66.00 | YR | M | Y | 88.00000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1158911520 | 11589115 | 1 | PS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, DAILY, CYCLIC (28 DAYS ON/14 DAYS OFF) | Y | 21938 | 50 | MG | CAPSULE, HARD | ||||||
| 1158911520 | 11589115 | 2 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, DAILY, CYCLIC (2 WEEKS ON/1 WEEK OFF) | Y | 21938 | 50 | MG | CAPSULE, HARD | ||||||
| 1158911520 | 11589115 | 3 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 37.5 MG, DAILY, CYCLIC (2 WEEKS ON/1 WEEK OFF) | Y | X731C | 21938 | 37.5 | MG | CAPSULE, HARD | |||||
| 1158911520 | 11589115 | 4 | SS | SUTENT | SUNITINIB MALATE | 1 | 25 MG, CYCLIC (14 DAYS ON AND 7 DAYS OFF) (2 WEEKS ON/1 WEEK OFF) | Y | 21938 | 25 | MG | CAPSULE, HARD | |||||||
| 1158911520 | 11589115 | 5 | SS | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | 2 MG, 1X/DAY, ONE TABLET ONCE A DAY | 2 | MG | Y | 0 | 2 | MG | TABLET | QD | |||
| 1158911520 | 11589115 | 6 | SS | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | 2 MG, 2X/DAY | 2 | MG | Y | 0 | 2 | MG | TABLET | BID | |||
| 1158911520 | 11589115 | 7 | SS | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | 2 MG, AS NEEDED (2,1,1,1 AND 1 ) | 2 | MG | Y | 0 | 2 | MG | TABLET | ||||
| 1158911520 | 11589115 | 8 | SS | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | 2 DF, 2X/DAY | 2 | MG | Y | 0 | 2 | DF | TABLET | BID | ||||
| 1158911520 | 11589115 | 9 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | 0 | |||||||||||
| 1158911520 | 11589115 | 10 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 0 | ||||||||||||
| 1158911520 | 11589115 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 1158911520 | 11589115 | 12 | C | METAMUCIL | PLANTAGO SEED | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1158911520 | 11589115 | 1 | Metastatic renal cell carcinoma |
| 1158911520 | 11589115 | 5 | Diarrhoea |
| 1158911520 | 11589115 | 9 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1158911520 | 11589115 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1158911520 | 11589115 | Abdominal pain upper | |
| 1158911520 | 11589115 | Acne | |
| 1158911520 | 11589115 | Blister | |
| 1158911520 | 11589115 | Bowel movement irregularity | |
| 1158911520 | 11589115 | Burning sensation | |
| 1158911520 | 11589115 | Chromaturia | |
| 1158911520 | 11589115 | Diarrhoea | |
| 1158911520 | 11589115 | Disease progression | |
| 1158911520 | 11589115 | Dyspepsia | |
| 1158911520 | 11589115 | Dyspnoea | |
| 1158911520 | 11589115 | Fatigue | |
| 1158911520 | 11589115 | Haematochezia | |
| 1158911520 | 11589115 | Haemorrhoids | |
| 1158911520 | 11589115 | Headache | |
| 1158911520 | 11589115 | Metastatic renal cell carcinoma | |
| 1158911520 | 11589115 | Muscle twitching | |
| 1158911520 | 11589115 | Nausea | |
| 1158911520 | 11589115 | Onychoclasis | |
| 1158911520 | 11589115 | Pain in extremity | |
| 1158911520 | 11589115 | Paraesthesia | |
| 1158911520 | 11589115 | Proctalgia | |
| 1158911520 | 11589115 | Pruritus | |
| 1158911520 | 11589115 | Rash | |
| 1158911520 | 11589115 | Terminal insomnia | |
| 1158911520 | 11589115 | Tooth fracture |
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 |
|---|---|---|---|---|---|---|
| 1158911520 | 11589115 | 1 | 20150908 | 0 | ||
| 1158911520 | 11589115 | 2 | 2015 | 0 | ||
| 1158911520 | 11589115 | 3 | 20151216 | 0 | ||
| 1158911520 | 11589115 | 4 | 20150908 | 0 | ||
| 1158911520 | 11589115 | 5 | 20151001 | 20151001 | 0 | |
| 1158911520 | 11589115 | 6 | 201510 | 0 | ||
| 1158911520 | 11589115 | 8 | 201511 | 201512 | 0 | |
| 1158911520 | 11589115 | 9 | 201505 | 201510 | 0 |