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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124208863 | 12420886 | 3 | F | 20160502 | 20160831 | 20160531 | 20160908 | PER | PHEH2016US013329 | NOVARTIS | 23.91 | YR | F | Y | 0.00000 | 20160908 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124208863 | 12420886 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | CODE NOT BROKEN | U | 22334 | TABLET | ||||||||
| 124208863 | 12420886 | 2 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Oral | CODE NOT BROKEN | U | 22334 | TABLET | ||||||||
| 124208863 | 12420886 | 3 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Oral | CODE NOT BROKEN | U | 22334 | TABLET | ||||||||
| 124208863 | 12420886 | 4 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 124208863 | 12420886 | 5 | C | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 124208863 | 12420886 | 6 | C | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124208863 | 12420886 | 1 | Angiomyolipoma |
| 124208863 | 12420886 | 2 | Angiomyolipoma |
| 124208863 | 12420886 | 3 | Angiomyolipoma |
| 124208863 | 12420886 | 4 | Product used for unknown indication |
| 124208863 | 12420886 | 5 | Product used for unknown indication |
| 124208863 | 12420886 | 6 | Acne |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124208863 | 12420886 | Abdominal pain | |
| 124208863 | 12420886 | Nausea | |
| 124208863 | 12420886 | Vaginal haemorrhage | |
| 124208863 | 12420886 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124208863 | 12420886 | 1 | 20131201 | 20160503 | 0 | |
| 124208863 | 12420886 | 2 | 20131201 | 20160503 | 0 | |
| 124208863 | 12420886 | 3 | 20131201 | 20160503 | 0 |