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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126748981 | 12674898 | 1 | I | 20150507 | 20150305 | 20160823 | 20160823 | EXP | US-ROCHE-1548883 | ROCHE | 69.02 | YR | F | Y | 42.91000 | KG | 20160823 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126748981 | 12674898 | 1 | PS | NUTROPIN AQ | SOMATROPIN | 1 | Subcutaneous | U | 608398 | 20522 | .3 | MG | SOLUTION FOR INJECTION | QD | |||||
| 126748981 | 12674898 | 2 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50723 | 500 | MG | TABLET | BID | ||||||
| 126748981 | 12674898 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 13/AUG/2015 | U | 50723 | 500 | MG | TABLET | TID | |||||
| 126748981 | 12674898 | 4 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 50723 | |||||||||||
| 126748981 | 12674898 | 5 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | U | 50723 | |||||||||||
| 126748981 | 12674898 | 6 | C | DHEA | PRASTERONE | 1 | Oral | 0 | 25 | MG | |||||||||
| 126748981 | 12674898 | 7 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | Unknown | 0 | 10 | MG | |||||||||
| 126748981 | 12674898 | 8 | C | RECLAST | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 0 | 5 | MG | |||||||||
| 126748981 | 12674898 | 9 | C | CORTEF | HYDROCORTISONE | 1 | Unknown | 20 MG AM, 20 MG PM | 0 | TABLET | |||||||||
| 126748981 | 12674898 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | 150 | UG | QD | ||||||||
| 126748981 | 12674898 | 11 | C | CYTOMEL | LIOTHYRONINE SODIUM | 1 | Oral | 0 | 25 | UG | TABLET | BID | |||||||
| 126748981 | 12674898 | 12 | C | FLORINEF ACETATE | FLUDROCORTISONE ACETATE | 1 | Unknown | 0 | .1 | MG | BID | ||||||||
| 126748981 | 12674898 | 13 | C | DDAVP | DESMOPRESSIN ACETATE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 14 | C | PANCREASE (UNITED STATES) | 2 | 0 | |||||||||||||
| 126748981 | 12674898 | 15 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 16 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 17 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | Unknown | 0 | 50 | MG | Q8H | ||||||||
| 126748981 | 12674898 | 18 | C | LYRICA | PREGABALIN | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 19 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 126748981 | 12674898 | 20 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 21 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | 0 | |||||||||||
| 126748981 | 12674898 | 22 | C | PREVACID | LANSOPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 126748981 | 12674898 | 23 | C | ALLEGRA-D | FEXOFENADINEPSEUDOEPHEDRINE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 24 | C | NASONEX | MOMETASONE FUROATE | 1 | Nasal | 0 | BID | ||||||||||
| 126748981 | 12674898 | 25 | C | CELEBREX | CELECOXIB | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 26 | C | LEVOCARNITINE. | LEVOCARNITINE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 27 | C | FAMVIR (UNITED STATES) | 2 | 0 | |||||||||||||
| 126748981 | 12674898 | 28 | C | LODINE | ETODOLAC | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 29 | C | PROVIGIL | MODAFINIL | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 30 | C | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 31 | C | DOXYCYCLIN | DOXYCYCLINE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 32 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 33 | C | ESTRACE | ESTRADIOL | 1 | Unknown | 0 | TABLET | QD | |||||||||
| 126748981 | 12674898 | 34 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 35 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | 0 | 75 | MG | BID | ||||||||
| 126748981 | 12674898 | 36 | C | ULTRAVATE OINTMENT 0.05% | 2 | 0 | |||||||||||||
| 126748981 | 12674898 | 37 | C | ZETIA | EZETIMIBE | 1 | Unknown | 0 | 10 | MG | |||||||||
| 126748981 | 12674898 | 38 | C | PROMETRIUM (UNITED STATES) | 2 | Unknown | 0 | 100 | MG | CAPSULE | |||||||||
| 126748981 | 12674898 | 39 | C | TRIAMCINOLONE ACETONIDE. | TRIAMCINOLONE ACETONIDE | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 40 | C | DEPO TESTOSTERONE | TESTOSTERONE | 1 | Unknown | 0 | .03 | ML | QOW | ||||||||
| 126748981 | 12674898 | 41 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | Unknown | 0 | |||||||||||
| 126748981 | 12674898 | 42 | C | SULFACETAMIDE SODIUM. | SULFACETAMIDE SODIUM | 1 | Unknown | 0 | 2 | GTT | |||||||||
| 126748981 | 12674898 | 43 | C | INSULIN | INSULIN NOS | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 44 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | 0 | TABLET | ||||||||||
| 126748981 | 12674898 | 45 | C | TRETINOIN. | TRETINOIN | 1 | Unknown | 0 | |||||||||||
| 126748981 | 12674898 | 46 | C | FISH OIL | FISH OIL | 1 | Oral | 0 | 1000 | MG | QD | ||||||||
| 126748981 | 12674898 | 47 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 126748981 | 12674898 | 48 | C | RETIN-A MICRO | TRETINOIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126748981 | 12674898 | 1 | Hypopituitarism |
| 126748981 | 12674898 | 2 | Polymyositis |
| 126748981 | 12674898 | 3 | Myalgia |
| 126748981 | 12674898 | 4 | Myositis |
| 126748981 | 12674898 | 5 | Connective tissue disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126748981 | 12674898 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126748981 | 12674898 | Alopecia | |
| 126748981 | 12674898 | Arthralgia | |
| 126748981 | 12674898 | Asthenia | |
| 126748981 | 12674898 | Constipation | |
| 126748981 | 12674898 | Diarrhoea | |
| 126748981 | 12674898 | Dizziness | |
| 126748981 | 12674898 | Extra dose administered | |
| 126748981 | 12674898 | Herpes simplex | |
| 126748981 | 12674898 | Injection site discolouration | |
| 126748981 | 12674898 | Insulin-like growth factor decreased | |
| 126748981 | 12674898 | Micturition urgency | |
| 126748981 | 12674898 | Muscle disorder | |
| 126748981 | 12674898 | Muscular weakness | |
| 126748981 | 12674898 | Myalgia | |
| 126748981 | 12674898 | Neck pain | |
| 126748981 | 12674898 | Peroneal nerve palsy | |
| 126748981 | 12674898 | Thyroid disorder | |
| 126748981 | 12674898 | Trichorrhexis | |
| 126748981 | 12674898 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 126748981 | 12674898 | 8 | 200807 | 0 |