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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124198493 | 12419849 | 3 | F | 201604 | 20160718 | 20160531 | 20160729 | EXP | US-GLAXOSMITHKLINE-US2016067825 | GLAXOSMITHKLINE | 24.74 | YR | F | Y | 56.69000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124198493 | 12419849 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, U | Y | W927A | 125370 | 600 | MG | SOLUTION FOR INJECTION | |||||
| 124198493 | 12419849 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 3 | C | TYLENOL | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 4 | C | LORATADINE. | LORATADINE | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 5 | C | FAMOTIDINE. | FAMOTIDINE | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 6 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK, QD | U | 0 | QD | |||||||||
| 124198493 | 12419849 | 8 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | 5 MG, QID | U | 0 | 5 | MG | QID | |||||||
| 124198493 | 12419849 | 9 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 10 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 11 | C | MIRENA | LEVONORGESTREL | 1 | U | 0 | |||||||||||
| 124198493 | 12419849 | 12 | C | ETHOSUXIMIDE. | ETHOSUXIMIDE | 1 | 250 MG, QID | U | 0 | 250 | MG | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124198493 | 12419849 | 1 | Systemic lupus erythematosus |
| 124198493 | 12419849 | 2 | Product used for unknown indication |
| 124198493 | 12419849 | 8 | Nausea |
| 124198493 | 12419849 | 9 | Headache |
| 124198493 | 12419849 | 10 | Pain |
| 124198493 | 12419849 | 12 | Seizure |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124198493 | 12419849 | Abdominal discomfort | |
| 124198493 | 12419849 | Alopecia | |
| 124198493 | 12419849 | Blood pressure increased | |
| 124198493 | 12419849 | Gastrointestinal pain | |
| 124198493 | 12419849 | Hypersensitivity | |
| 124198493 | 12419849 | Hypertension | |
| 124198493 | 12419849 | Migraine | |
| 124198493 | 12419849 | Nausea | |
| 124198493 | 12419849 | Sensation of foreign body | |
| 124198493 | 12419849 | Throat tightness |
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 |
|---|---|---|---|---|---|---|
| 124198493 | 12419849 | 1 | 20160416 | 20160430 | 0 |