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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126403231 | 12640323 | 1 | I | 201010 | 20110926 | 20160810 | 20160810 | EXP | US-VALIDUS PHARMACEUTICALS LLC-US-2011VAL000448 | VALIDUS | 0.00 | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126403231 | 12640323 | 1 | PS | CALCITRIOL. | CALCITRIOL | 1 | Unknown | 0.125 ?G, 1 IN 1 D | U | 18044 | .125 | UG | |||||||
| 126403231 | 12640323 | 2 | SS | CALCITRIOL. | CALCITRIOL | 1 | Unknown | 0.7 ?G, 1 IN 1 D | U | 18044 | .7 | UG | |||||||
| 126403231 | 12640323 | 3 | SS | NUTROPIN AQ | SOMATROPIN | 1 | Subcutaneous | 0.5 MG,1 IN 1 D | U | 0 | .5 | MG | SOLUTION FOR INJECTION | ||||||
| 126403231 | 12640323 | 4 | C | EPOGEN | ERYTHROPOIETIN | 1 | 1000 UNITS | U | 0 | 1000 | DF | ||||||||
| 126403231 | 12640323 | 5 | C | EPOGEN | ERYTHROPOIETIN | 1 | 1500 UNITS | U | 0 | 1500 | DF | ||||||||
| 126403231 | 12640323 | 6 | C | IRON SULPHATE | FERROUS SULFATE ANHYDROUS | 1 | /ML 15 MG,2 IN 1 D | U | 0 | 15 | MG | ||||||||
| 126403231 | 12640323 | 7 | C | NA PHOSPHATE | SODIUM PHOSPHATE | 1 | 0.7 ML,2 IN 1 D | U | 0 | .7 | ML | ||||||||
| 126403231 | 12640323 | 8 | C | NA PHOSPHATE | SODIUM PHOSPHATE | 1 | 1.4 ML,1 IN 1 D | U | 0 | 1.4 | ML | ||||||||
| 126403231 | 12640323 | 9 | C | NEPHRONEX | 2 | 1 ML,1 IN 1 D | U | 0 | 1 | ML | |||||||||
| 126403231 | 12640323 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0.0125 MG,1 IN 1 D | U | 0 | .012 | MG | ||||||||
| 126403231 | 12640323 | 11 | C | LACTOBACILLUS | LACTOBACILLUS ACIDOPHILUS | 1 | 1PKT 1 IN 1 D | U | 0 | 1 | DF | ||||||||
| 126403231 | 12640323 | 12 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | 1TSP 1 D | U | 0 | ||||||||||
| 126403231 | 12640323 | 13 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | 1.25 ML,1 IN 1 M | U | 0 | 1.25 | ML | ||||||||
| 126403231 | 12640323 | 14 | C | CACO3 | 2 | UNK | U | 0 | |||||||||||
| 126403231 | 12640323 | 15 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | ||||||||||
| 126403231 | 12640323 | 16 | C | RANITIDINE. | RANITIDINE | 1 | 15 MG,2 IN 1 D | U | 0 | 15 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126403231 | 12640323 | 1 | Product used for unknown indication |
| 126403231 | 12640323 | 3 | Growth hormone deficiency |
| 126403231 | 12640323 | 4 | Product used for unknown indication |
| 126403231 | 12640323 | 6 | Product used for unknown indication |
| 126403231 | 12640323 | 7 | Product used for unknown indication |
| 126403231 | 12640323 | 9 | Product used for unknown indication |
| 126403231 | 12640323 | 10 | Product used for unknown indication |
| 126403231 | 12640323 | 11 | Product used for unknown indication |
| 126403231 | 12640323 | 12 | Product used for unknown indication |
| 126403231 | 12640323 | 13 | Product used for unknown indication |
| 126403231 | 12640323 | 14 | Product used for unknown indication |
| 126403231 | 12640323 | 15 | Product used for unknown indication |
| 126403231 | 12640323 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126403231 | 12640323 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126403231 | 12640323 | Cardiac murmur | |
| 126403231 | 12640323 | Developmental delay | |
| 126403231 | 12640323 | Gastrooesophageal reflux disease | |
| 126403231 | 12640323 | Local swelling | |
| 126403231 | 12640323 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |