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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124885682 | 12488568 | 2 | F | 2016 | 20160705 | 20160622 | 20160714 | EXP | PHHY2016US060868 | SANDOZ | 55.18 | YR | M | Y | 0.00000 | 20160714 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124885682 | 12488568 | 1 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 5 MG, BID | AE2923K | 0 | 5 | MG | TABLET | BID | |||||
124885682 | 12488568 | 2 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 5 MG, BID | 1402630BB | 0 | 5 | MG | TABLET | BID | |||||
124885682 | 12488568 | 3 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 2.5 MG (0.5 TABLET), BID | 0 | 2.5 | MG | TABLET | BID | ||||||
124885682 | 12488568 | 4 | PS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, UNK | 850 | MG | 80336 | ||||||||
124885682 | 12488568 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | LOW DOSE | 850 | MG | 80336 | ||||||||
124885682 | 12488568 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | UNK UNK, QD | 850 | MG | 80336 | ||||||||
124885682 | 12488568 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 65 MG, QD | 850 | MG | 80336 | 65 | MG | QD | |||||
124885682 | 12488568 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 55 MG, QD | 850 | MG | 80336 | 55 | MG | QD | |||||
124885682 | 12488568 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 50 MG, QD | 850 | MG | 80336 | 50 | MG | QD | |||||
124885682 | 12488568 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 40 MG, QD | 850 | MG | 80336 | 40 | MG | QD | |||||
124885682 | 12488568 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 45 MG, QD (DAILY) | 850 | MG | 80336 | 45 | MG | QD | |||||
124885682 | 12488568 | 12 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 0 | |||||||||||
124885682 | 12488568 | 13 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | 0 | |||||||||||
124885682 | 12488568 | 14 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | 80 MG, BID | 960 | MG | 0 | 80 | MG | BID | |||||
124885682 | 12488568 | 15 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | 80 MG, BID | 960 | MG | 0 | 80 | MG | BID | |||||
124885682 | 12488568 | 16 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | 80 MG, BID | 960 | MG | 0 | 80 | MG | BID | |||||
124885682 | 12488568 | 17 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | 400 MG, BID (2 TIMES A DAY) | 0 | 400 | MG | BID | |||||||
124885682 | 12488568 | 18 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Oral | 250 MG, QD, (EVERY 24 HOURS) | 0 | 250 | MG | QD | |||||||
124885682 | 12488568 | 19 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Oral | 250 MG, QD (EVERY 24 HOURS) | 0 | 250 | MG | ||||||||
124885682 | 12488568 | 20 | C | CEFADROXIL. | CEFADROXIL | 1 | Oral | UNK, Q12H | 0 | Q12H | |||||||||
124885682 | 12488568 | 21 | C | CEFADROXIL. | CEFADROXIL | 1 | Oral | 500 MG, Q12H | 0 | ||||||||||
124885682 | 12488568 | 22 | C | PENTAMIDINE | PENTAMIDINE | 1 | Unknown | 300 MG, QMO | 0 | 300 | MG | /month | |||||||
124885682 | 12488568 | 23 | C | PENTAMIDINE | PENTAMIDINE | 1 | Unknown | 300 MG, ONCE A MONTH | 0 | ||||||||||
124885682 | 12488568 | 24 | C | POSACONAZOLE | POSACONAZOLE | 1 | Oral | TABLETS QD (EVERY 24 HOURS) | 0 | 3 | DF | QD | |||||||
124885682 | 12488568 | 25 | C | POSACONAZOLE | POSACONAZOLE | 1 | Oral | 3 TABLETS QD (EVERY 24 HOURS) | 0 | ||||||||||
124885682 | 12488568 | 26 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 2 DF, 2 PUFFS (4 TIME) | 0 | 2 | DF | QID | |||||||
124885682 | 12488568 | 27 | C | ALPHA LIPOIC | 2 | Oral | 300 MG,BID (2 TIMES A DAY) | 0 | 300 | MG | BID | ||||||||
124885682 | 12488568 | 28 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 10 MG, QD (EVERY 24 HOURS) | 0 | 10 | MG | QD | |||||||
124885682 | 12488568 | 29 | C | AMMONIUM LACTATE. | AMMONIUM LACTATE | 1 | Topical | UNK, BID | 0 | ||||||||||
124885682 | 12488568 | 30 | C | AMMONIUM LACTATE. | AMMONIUM LACTATE | 1 | Topical | 1 APPLICATION, BID (2 TIMES A DAY) | 0 | ||||||||||
124885682 | 12488568 | 31 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 10 ML, TID (3 TIMES A DAY) | 0 | ||||||||||
124885682 | 12488568 | 32 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 10 ML, TID (3 TIMES A DAY) | 0 | 10 | ML | ||||||||
124885682 | 12488568 | 33 | C | LABETALOL | LABETALOLLABETALOL HYDROCHLORIDE | 1 | Oral | 400 MG, TID (3 TIMES A DAY) (Q8H) | 0 | 400 | MG | ||||||||
124885682 | 12488568 | 34 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 25 MCG (0.025 MG), QD (ONCE A DAY) | 0 | 25 | UG | QD | |||||||
124885682 | 12488568 | 35 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | TAPERED OFF | 0 | ||||||||||
124885682 | 12488568 | 36 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | TAPERED OFF | 0 | ||||||||||
124885682 | 12488568 | 37 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | UNK | 0 | ||||||||||
124885682 | 12488568 | 38 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1 G, UNK | 0 | 1 | G | ||||||||
124885682 | 12488568 | 39 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1000 MG, BID | 0 | 1000 | MG | BID | |||||||
124885682 | 12488568 | 40 | C | MUPIROCIN. | MUPIROCIN | 1 | Topical | UNK, BID, 1 APPLICATION 2 TIMES A DAY | 0 | BID | |||||||||
124885682 | 12488568 | 41 | C | MUPIROCIN. | MUPIROCIN | 1 | Topical | 1 APPLICATION 2 TIMES A DAY | 0 | ||||||||||
124885682 | 12488568 | 42 | C | OMEGA 3 /01333901/ | FISH OILTOCOPHEROL | 1 | Oral | 1200 MG Q12H (EVERY 12 HOURS) | 0 | 1200 | MG | Q12H | |||||||
124885682 | 12488568 | 43 | C | PROTONIX//OMEPRAZOLE | OMEPRAZOLE | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
124885682 | 12488568 | 44 | C | SILVER SULFADIAZINE. | SILVER SULFADIAZINE | 1 | Topical | APPLICATION Q12H (EVERY 12 HOURS)1 DF, Q12H | 0 | 1 | DF | Q12H | |||||||
124885682 | 12488568 | 45 | C | SILVER SULFADIAZINE. | SILVER SULFADIAZINE | 1 | Topical | 1 APPLICATION Q12H (EVERY 12 HOURS) | 0 | ||||||||||
124885682 | 12488568 | 46 | C | HYDROMORPHONE | HYDROMORPHONE | 1 | Oral | 1 DF, Q4H 1 TABLET, PRN (EVERY 4 HOURS, AS NEEDED) | 0 | 1 | DF | Q4H | |||||||
124885682 | 12488568 | 47 | C | HYDROMORPHONE | HYDROMORPHONE | 1 | Oral | 1 TABLET Q4H, PRN (EVERY 4 HOURS, AS NEEDED) | 0 | ||||||||||
124885682 | 12488568 | 48 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | 500 MG, BID (2 TIMES A DAY) | 0 | 500 | MG | BID | |||||||
124885682 | 12488568 | 49 | C | K-TAB | POTASSIUM CHLORIDE | 1 | Oral | 20 MEQ (1 TABLET QD (ONCE A DAY) | 0 | 20 | MEQ | QD | |||||||
124885682 | 12488568 | 50 | C | K-TAB | POTASSIUM CHLORIDE | 1 | Oral | 20 MEQ (1 TABLET QD (ONCE A DAY)) | 0 | ||||||||||
124885682 | 12488568 | 51 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | Oral | 2000 IU, QD (DAILY) | 0 | 2000 | IU | QD | |||||||
124885682 | 12488568 | 52 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | Oral | 50000 IU (1.25 MG), ONCE A WEEK | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
124885682 | 12488568 | 1 | Chronic graft versus host disease |
124885682 | 12488568 | 2 | Mantle cell lymphoma |
124885682 | 12488568 | 3 | Off label use |
124885682 | 12488568 | 4 | Chronic graft versus host disease |
124885682 | 12488568 | 12 | Product used for unknown indication |
124885682 | 12488568 | 13 | Product used for unknown indication |
124885682 | 12488568 | 14 | Product used for unknown indication |
124885682 | 12488568 | 17 | Antiviral prophylaxis |
124885682 | 12488568 | 18 | Prophylaxis |
124885682 | 12488568 | 20 | Prophylaxis |
124885682 | 12488568 | 22 | Prophylaxis |
124885682 | 12488568 | 24 | Antifungal prophylaxis |
124885682 | 12488568 | 26 | Dyspnoea |
124885682 | 12488568 | 27 | Neuropathy peripheral |
124885682 | 12488568 | 28 | Hypertension |
124885682 | 12488568 | 29 | Prophylaxis |
124885682 | 12488568 | 31 | Graft versus host disease |
124885682 | 12488568 | 33 | Hypertension |
124885682 | 12488568 | 34 | Thyroid hormone replacement therapy |
124885682 | 12488568 | 35 | Graft versus host disease |
124885682 | 12488568 | 40 | Skin ulcer |
124885682 | 12488568 | 41 | Wound treatment |
124885682 | 12488568 | 42 | Supplementation therapy |
124885682 | 12488568 | 43 | Prophylaxis against gastrointestinal ulcer |
124885682 | 12488568 | 44 | Wound treatment |
124885682 | 12488568 | 46 | Pain |
124885682 | 12488568 | 48 | Supplementation therapy |
124885682 | 12488568 | 49 | Supplementation therapy |
124885682 | 12488568 | 51 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
124885682 | 12488568 | OT |
124885682 | 12488568 | DE |
124885682 | 12488568 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124885682 | 12488568 | Anaemia | |
124885682 | 12488568 | Anal incontinence | |
124885682 | 12488568 | Asthenia | |
124885682 | 12488568 | Back pain | |
124885682 | 12488568 | Blood immunoglobulin G decreased | |
124885682 | 12488568 | Coronavirus test positive | |
124885682 | 12488568 | Cough | |
124885682 | 12488568 | Death | |
124885682 | 12488568 | Deep vein thrombosis | |
124885682 | 12488568 | Dyspnoea | |
124885682 | 12488568 | Enterococcal infection | |
124885682 | 12488568 | Epistaxis | |
124885682 | 12488568 | Fall | |
124885682 | 12488568 | Fatigue | |
124885682 | 12488568 | Fractured sacrum | |
124885682 | 12488568 | Hypoaesthesia | |
124885682 | 12488568 | Hypoxia | |
124885682 | 12488568 | Leukopenia | |
124885682 | 12488568 | Medication error | |
124885682 | 12488568 | Oedema peripheral | |
124885682 | 12488568 | Off label use | |
124885682 | 12488568 | Pancytopenia | |
124885682 | 12488568 | Pneumonia | |
124885682 | 12488568 | Pulmonary embolism | |
124885682 | 12488568 | Scleroderma | |
124885682 | 12488568 | Skin ulcer | |
124885682 | 12488568 | Thrombocytopenia | |
124885682 | 12488568 | Tremor | |
124885682 | 12488568 | Weight decreased | |
124885682 | 12488568 | White blood cell count decreased |
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 |
---|---|---|---|---|---|---|
124885682 | 12488568 | 2 | 201603 | 20160427 | 0 | |
124885682 | 12488568 | 3 | 20160427 | 0 | ||
124885682 | 12488568 | 4 | 20150325 | 0 | ||
124885682 | 12488568 | 5 | 20151106 | 0 | ||
124885682 | 12488568 | 6 | 20151106 | 0 | ||
124885682 | 12488568 | 7 | 201512 | 0 | ||
124885682 | 12488568 | 8 | 20160510 | 0 | ||
124885682 | 12488568 | 9 | 20160510 | 20160526 | 0 | |
124885682 | 12488568 | 11 | 20160526 | 0 | ||
124885682 | 12488568 | 15 | 20160413 | 20160418 | 0 | |
124885682 | 12488568 | 16 | 20160419 | 20160421 | 0 | |
124885682 | 12488568 | 33 | 20160216 | 0 | ||
124885682 | 12488568 | 35 | 20141118 | 0 | ||
124885682 | 12488568 | 36 | 201503 | 0 | ||
124885682 | 12488568 | 37 | 20151229 | 0 | ||
124885682 | 12488568 | 38 | 20160605 | 0 | ||
124885682 | 12488568 | 39 | 20160605 | 0 |