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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126408511 | 12640851 | 1 | I | 20121221 | 20160810 | 20160810 | EXP | US-VALIDUS PHARMACEUTICALS LLC-US-2012VAL000726 | VALIDUS | 0.00 | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126408511 | 12640851 | 1 | PS | ROCALTROL | CALCITRIOL | 1 | Oral | 3 ?G (0.5 ?G, 6 IN 1 D) | U | 18044 | .5 | UG | CAPSULE | ||||||
| 126408511 | 12640851 | 2 | SS | NUTROPIN AQ | SOMATROPIN | 1 | Subcutaneous | 1.6 MG (1.6 MG, 1 IN 1 D) | U | 0 | 1.6 | MG | SOLUTION FOR INJECTION | ||||||
| 126408511 | 12640851 | 3 | SS | NUTROPIN AQ | SOMATROPIN | 1 | Subcutaneous | 1.4 MG, 1 IN 1 D | U | 0 | 1.4 | MG | SOLUTION FOR INJECTION | ||||||
| 126408511 | 12640851 | 4 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 75 ?G, 1 IN 1 D | U | 0 | TABLET | ||||||||
| 126408511 | 12640851 | 5 | C | BICITRA /00586801/ | 2 | Oral | 15 ML, 1 IN 1 D | U | 0 | ORAL SOLUTION | |||||||||
| 126408511 | 12640851 | 6 | C | NEPHRO-VITE /01801401/ | 2 | Oral | 1 IN 1 D | U | 0 | TABLET | |||||||||
| 126408511 | 12640851 | 7 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | HALF PER DAY (17 G) | U | 0 | 17 | G | |||||||
| 126408511 | 12640851 | 8 | C | TUMS /00193601/ | CALCIUM CARBONATEMAGNESIUM CARBONATEMAGNESIUM TRISILICATE | 1 | Oral | 500 MG, 1 IN 1 D | U | 0 | 500 | MG | TABLET | ||||||
| 126408511 | 12640851 | 9 | C | PPD | TUBERCULIN PURIFIED PROTEIN DERIVATIVE | 1 | UNK | U | 0 | ||||||||||
| 126408511 | 12640851 | 10 | C | PPD | TUBERCULIN PURIFIED PROTEIN DERIVATIVE | 1 | UNK | U | 0 | ||||||||||
| 126408511 | 12640851 | 11 | C | PPD | TUBERCULIN PURIFIED PROTEIN DERIVATIVE | 1 | UNK | U | 0 | ||||||||||
| 126408511 | 12640851 | 12 | C | PNEUMOVAX 23 | PNEUMOCOCCAL VACCINE, POLYVALENT 23 | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126408511 | 12640851 | 1 | Product used for unknown indication |
| 126408511 | 12640851 | 2 | Body height below normal |
| 126408511 | 12640851 | 3 | Chronic kidney disease |
| 126408511 | 12640851 | 4 | Product used for unknown indication |
| 126408511 | 12640851 | 5 | Product used for unknown indication |
| 126408511 | 12640851 | 6 | Product used for unknown indication |
| 126408511 | 12640851 | 7 | Product used for unknown indication |
| 126408511 | 12640851 | 8 | Product used for unknown indication |
| 126408511 | 12640851 | 9 | Product used for unknown indication |
| 126408511 | 12640851 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126408511 | 12640851 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126408511 | 12640851 | Headache | |
| 126408511 | 12640851 | Hypocalcaemia | |
| 126408511 | 12640851 | Hypothyroidism | |
| 126408511 | 12640851 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 126408511 | 12640851 | 2 | 201207 | 0 | ||
| 126408511 | 12640851 | 9 | 20100713 | 0 | ||
| 126408511 | 12640851 | 10 | 20110310 | 0 | ||
| 126408511 | 12640851 | 11 | 20120628 | 0 | ||
| 126408511 | 12640851 | 12 | 20120601 | 0 |