2017-11-16 - Female - 28 Years old
901580304
| Adverse reaction report number | 901580304 |
| Latest AER version number | 0 |
| Market authorization holder AER number | 15P-028-1432881-00 |
| Initial received date | 2017-11-16 |
| Latest received date | 2017-11-16 |
| Age | 28 Years |
| Gender | Female |
| Weight | 83 Kilograms |
| Type of report | Study |
| Reporter type | Physician |
| Source of report | Clinical Study |
| Report outcome | Recovered/resolved |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | |
| Other medically important | Yes |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| COMBIVIR | TABLET | Suspect | Oral | 2 every 1 Day(s) | 100 Day(s) | HIV infection | |
| KALETRA | NOT SPECIFIED | Suspect | Oral | 2 Dosage forms | 2 every 1 Day(s) | Antiretroviral therapy | |
| KALETRA | NOT SPECIFIED | Suspect | Oral | 2 Dosage forms | 2 every 1 Day(s) | HIV infection | |
| KALETRA | TABLET | Suspect | Oral | 100 Day(s) | Antiretroviral therapy | ||
| KALETRA | TABLET | Suspect | Oral | 100 Day(s) | HIV infection | ||
| TRUVADA | TABLET | Suspect | Oral | 1 Dosage forms | 1 every 1 Day(s) | Antiretroviral therapy | |
| TRUVADA | TABLET | Suspect | Oral | 1 Dosage forms | 1 every 1 Day(s) | HIV infection |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug-induced liver injury | 55 Day(s) |
| Exposure during pregnancy | |
| Live birth | |
| Liver function test increased | 55 Day(s) |
| Vomiting | |