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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113888394 | 11388839 | 4 | F | 20150513 | 20160714 | 20150817 | 20160720 | PER | PHEH2015US009963 | NOVARTIS | 52.74 | YR | F | Y | 0.00000 | 20160720 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113888394 | 11388839 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 2.5 MG, QD | 22334 | 2.5 | MG | QD | |||||||
| 113888394 | 11388839 | 2 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | U | 0 | ||||||||||
| 113888394 | 11388839 | 3 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 113888394 | 11388839 | 4 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 113888394 | 11388839 | 5 | C | DISURYL | 2 | Unknown | U | 0 | |||||||||||
| 113888394 | 11388839 | 6 | C | ASCORBIC ACID. | ASCORBIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 113888394 | 11388839 | 7 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Unknown | U | 0 | ||||||||||
| 113888394 | 11388839 | 8 | C | MULTI VITAMIN | VITAMINS | 1 | Unknown | U | 0 | ||||||||||
| 113888394 | 11388839 | 9 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113888394 | 11388839 | 1 | Tuberous sclerosis |
| 113888394 | 11388839 | 2 | Product used for unknown indication |
| 113888394 | 11388839 | 3 | Supplementation therapy |
| 113888394 | 11388839 | 4 | Product used for unknown indication |
| 113888394 | 11388839 | 5 | Product used for unknown indication |
| 113888394 | 11388839 | 6 | Product used for unknown indication |
| 113888394 | 11388839 | 7 | Product used for unknown indication |
| 113888394 | 11388839 | 8 | Product used for unknown indication |
| 113888394 | 11388839 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113888394 | 11388839 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113888394 | 11388839 | Animal bite | |
| 113888394 | 11388839 | Epistaxis | |
| 113888394 | 11388839 | Fatigue | |
| 113888394 | 11388839 | Lipase increased | |
| 113888394 | 11388839 | Lymphangioleiomyomatosis | |
| 113888394 | 11388839 | Muscle spasms | |
| 113888394 | 11388839 | Nail disorder | |
| 113888394 | 11388839 | Onychoclasis | |
| 113888394 | 11388839 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 113888394 | 11388839 | 1 | 201403 | 0 |