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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121801265 | 12180126 | 5 | F | 20160307 | 20160729 | 20160315 | 20160809 | EXP | US-PFIZER INC-2016137037 | PFIZER | 83.00 | YR | F | Y | 58.97000 | KG | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121801265 | 12180126 | 1 | PS | SUTENT | SUNITINIB MALATE | 1 | Oral | 25 MG, CYCLIC (28 DAYS ON/14 DAYS OFF) | 21938 | 25 | MG | CAPSULE, HARD | |||||||
| 121801265 | 12180126 | 2 | C | CLONIDINE. | CLONIDINE | 1 | Oral | 0.10 MG, 2X/DAY | 0 | .1 | MG | TABLET | BID | ||||||
| 121801265 | 12180126 | 3 | C | CLONIDINE. | CLONIDINE | 1 | UNK | 0 | TABLET | ||||||||||
| 121801265 | 12180126 | 4 | C | DULOXETINE. | DULOXETINE | 1 | 30 MG, DAILY | 0 | 30 | MG | CAPSULE | ||||||||
| 121801265 | 12180126 | 5 | C | DULOXETINE. | DULOXETINE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 121801265 | 12180126 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, 1X/DAY (ONCE AT BEDTIME | 0 | 300 | MG | CAPSULE | QD | ||||||
| 121801265 | 12180126 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | 0 | CAPSULE | ||||||||||
| 121801265 | 12180126 | 8 | C | LABETALOL | LABETALOLLABETALOL HYDROCHLORIDE | 1 | Oral | 100 MG, 2X/DAY | 0 | 100 | MG | TABLET | BID | ||||||
| 121801265 | 12180126 | 9 | C | LABETALOL | LABETALOLLABETALOL HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 121801265 | 12180126 | 10 | C | THYROXINE | LEVOTHYROXINE | 1 | 25 UG, 1X/DAY (1 TAB IN THE MORNING) | 0 | 25 | UG | TABLET | QD | |||||||
| 121801265 | 12180126 | 11 | C | THYROXINE | LEVOTHYROXINE | 1 | UNK | 0 | TABLET | ||||||||||
| 121801265 | 12180126 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 1 MG, AS NEEDED (EVERY 8 HOURS AS NEEDED) | 0 | 1 | MG | TABLET | |||||||
| 121801265 | 12180126 | 13 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | 0 | TABLET | ||||||||||
| 121801265 | 12180126 | 14 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Oral | 5 MG, 2X/DAY | 0 | 5 | MG | TABLET | BID | ||||||
| 121801265 | 12180126 | 15 | C | TEMAZEPAM. | TEMAZEPAM | 1 | 30 MG, 1X/DAY (ONE CAPSULE AT BEDTIME) | 0 | 30 | MG | CAPSULE | QD | |||||||
| 121801265 | 12180126 | 16 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 50 MG, 4X/DAY (EVERY 6 HOURS) | 0 | 50 | MG | QID | |||||||
| 121801265 | 12180126 | 17 | C | TRAMADOL. | TRAMADOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121801265 | 12180126 | 1 | Metastatic renal cell carcinoma |
| 121801265 | 12180126 | 2 | Blood pressure abnormal |
| 121801265 | 12180126 | 4 | Anxiety |
| 121801265 | 12180126 | 5 | Depression |
| 121801265 | 12180126 | 6 | Seizure |
| 121801265 | 12180126 | 8 | Blood pressure abnormal |
| 121801265 | 12180126 | 10 | Thyroid disorder |
| 121801265 | 12180126 | 12 | Anxiety |
| 121801265 | 12180126 | 14 | Urinary tract discomfort |
| 121801265 | 12180126 | 15 | Sleep disorder |
| 121801265 | 12180126 | 16 | Headache |
| 121801265 | 12180126 | 17 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121801265 | 12180126 | DE |
| 121801265 | 12180126 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121801265 | 12180126 | Asthenia | |
| 121801265 | 12180126 | Dental plaque | |
| 121801265 | 12180126 | Diarrhoea | |
| 121801265 | 12180126 | Disorientation | |
| 121801265 | 12180126 | Dyspepsia | |
| 121801265 | 12180126 | Dysphagia | |
| 121801265 | 12180126 | Hypophagia | |
| 121801265 | 12180126 | Mobility decreased | |
| 121801265 | 12180126 | Oral mucosal exfoliation | |
| 121801265 | 12180126 | Tooth loss | |
| 121801265 | 12180126 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 121801265 | 12180126 | 1 | 20160301 | 0 | ||
| 121801265 | 12180126 | 3 | 201503 | 0 | ||
| 121801265 | 12180126 | 5 | 201503 | 0 | ||
| 121801265 | 12180126 | 7 | 201503 | 0 | ||
| 121801265 | 12180126 | 9 | 201503 | 0 | ||
| 121801265 | 12180126 | 11 | 201503 | 0 | ||
| 121801265 | 12180126 | 13 | 201503 | 0 |