Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Metronidazole Actavis · 1 trial · 1 indication
Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.
Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.
| Arm | Type | Description |
|---|---|---|
| Prevention (Erlotinib + Metronidazole Actavis) | EXPERIMENTAL | Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). |
| Treatment (Erlotinib + Metronidazole Actavis) | EXPERIMENTAL | Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). |
| Name | Type | Description |
|---|---|---|
| Erlotinib | DRUG | Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks. |
| Metronidazole Actavis | DRUG | Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks. |
| Non-active Moisturizing Cream | OTHER | Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). |
Inclusion Criteria: * non-small cell lung cancer * eligible to start treatment with erlotinib Exclusion Criteria: * hypersensitivity to metronidazole