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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126425891 | 12642589 | 1 | I | 20160715 | 20160720 | 20160810 | 20160810 | PER | GXBR2016US002306 | SANDOZ | 39.70 | YR | F | Y | 55.33000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126425891 | 12642589 | 1 | PS | LEUPROLIDE ACETATE. | LEUPROLIDE ACETATE | 1 | Subcutaneous | 1 DF, QD | Y | 0300024 | 74728 | 1 | DF | INJECTION | QD | ||||
| 126425891 | 12642589 | 2 | SS | LEUPROLIDE ACETATE. | LEUPROLIDE ACETATE | 1 | Subcutaneous | 2 DF, UNK | Y | 74728 | 2 | DF | INJECTION | QD | |||||
| 126425891 | 12642589 | 3 | SS | LEUPROLIDE ACETATE. | LEUPROLIDE ACETATE | 1 | Subcutaneous | 1 DF, QD | Y | 74728 | 1 | DF | INJECTION | QD | |||||
| 126425891 | 12642589 | 4 | SS | OMNITROPE | SOMATROPIN | 1 | Subcutaneous | 25 U, QD | Y | 0 | 25 | DF | INJECTION | QD | |||||
| 126425891 | 12642589 | 5 | C | GONAL-F | FOLLITROPIN | 1 | Subcutaneous | 225 IU, QD | 0 | 225 | IU | QD | |||||||
| 126425891 | 12642589 | 6 | C | MENOPUR | FOLLICLE STIMULATING HORMONE BETA POLYPEPTIDELUTROPIN ALFA | 1 | Subcutaneous | 150MG IU, QD | 0 | 150 | IU | QD | |||||||
| 126425891 | 12642589 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 1 MG, QD | 0 | 1 | MG | QD | |||||||
| 126425891 | 12642589 | 8 | C | SUMATRIPTAN. | SUMATRIPTAN | 1 | Unknown | 50 MG, PRN | 0 | 50 | MG | ||||||||
| 126425891 | 12642589 | 9 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Nasal | UNK DF, PRN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126425891 | 12642589 | 1 | Infertility |
| 126425891 | 12642589 | 4 | Infertility |
| 126425891 | 12642589 | 5 | Infertility |
| 126425891 | 12642589 | 6 | Infertility |
| 126425891 | 12642589 | 7 | Infertility |
| 126425891 | 12642589 | 8 | Migraine |
| 126425891 | 12642589 | 9 | Hypersensitivity |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126425891 | 12642589 | Arthralgia | |
| 126425891 | 12642589 | Fatigue | |
| 126425891 | 12642589 | Myalgia | |
| 126425891 | 12642589 | Overdose |
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 |
|---|---|---|---|---|---|---|
| 126425891 | 12642589 | 1 | 20160715 | 20160715 | 0 | |
| 126425891 | 12642589 | 2 | 20160716 | 20160718 | 0 | |
| 126425891 | 12642589 | 3 | 20160719 | 20160719 | 0 | |
| 126425891 | 12642589 | 4 | 20160715 | 20160719 | 0 | |
| 126425891 | 12642589 | 5 | 20160715 | 20160719 | 0 | |
| 126425891 | 12642589 | 6 | 20160715 | 20160719 | 0 | |
| 126425891 | 12642589 | 7 | 20160715 | 20160719 | 0 |