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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125440921 | 12544092 | 1 | I | 201512 | 20160627 | 20160711 | 20160711 | EXP | GB-MHRA-EYC 00141364 | GB-LUPIN PHARMACEUTICALS INC.-E2B_00005762 | LUPIN | 62.00 | YR | F | Y | 84.00000 | KG | 20160711 | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125440921 | 12544092 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 25 MG | Y | U | UNKNOWN | 77670 | |||||||
| 125440921 | 12544092 | 2 | I | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 100 MG | Y | U | UNKNOWN | 77670 | |||||||
| 125440921 | 12544092 | 3 | I | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 150MG | Y | U | UNKNOWN | 77670 | |||||||
| 125440921 | 12544092 | 4 | I | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | DOSE REDUCED | Y | U | UNKNOWN | 77670 | |||||||
| 125440921 | 12544092 | 5 | I | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125440921 | 12544092 | 6 | I | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | INCREASED DOSE | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125440921 | 12544092 | 1 | Anxiety |
| 125440921 | 12544092 | 5 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125440921 | 12544092 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125440921 | 12544092 | Blood thyroid stimulating hormone increased | |
| 125440921 | 12544092 | Inhibitory drug interaction | |
| 125440921 | 12544092 | Malaise |
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 |
|---|---|---|---|---|---|---|
| 125440921 | 12544092 | 1 | 201505 | 0 | ||
| 125440921 | 12544092 | 2 | 201512 | 0 | ||
| 125440921 | 12544092 | 3 | 201512 | 201605 | 0 | |
| 125440921 | 12544092 | 4 | 201605 | 0 |