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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127095451 | 12709545 | 1 | I | 20160818 | 20160902 | 20160902 | EXP | DE-ALKEM LABORATORIES LIMITED-DE-ALKEM-2016-00156 | ALKEM | 44.00 | YR | F | Y | 84.00000 | KG | 20160902 | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127095451 | 12709545 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Oral | 5 MG, OD | 202295 | 5 | MG | Q12H | |||||||
| 127095451 | 12709545 | 2 | C | FEMIBION | VITAMINS | 1 | Oral | 0.4 MG, OD | 0 | .4 | MG | Q12H | |||||||
| 127095451 | 12709545 | 3 | C | NOVORAPID | INSULIN ASPART | 1 | Subcutaneous | UNKNOWN | 0 | ||||||||||
| 127095451 | 12709545 | 4 | C | PROTAPHANE | INSULIN HUMAN | 1 | Subcutaneous | 36 [I.E./D (BIS 15 I.E./D) ] | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127095451 | 12709545 | 1 | Psychotic disorder |
| 127095451 | 12709545 | 2 | Prophylaxis of neural tube defect |
| 127095451 | 12709545 | 3 | Gestational diabetes |
| 127095451 | 12709545 | 4 | Gestational diabetes |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127095451 | 12709545 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127095451 | 12709545 | Exposure during pregnancy | |
| 127095451 | 12709545 | Gestational diabetes | |
| 127095451 | 12709545 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127095451 | 12709545 | 1 | 20150815 | 20160513 | 0 | |
| 127095451 | 12709545 | 2 | 20150815 | 20160513 | 0 |