Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.
Interventions
DRUGErlotinib
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
DRUGMetronidazole Actavis
Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
OTHERNon-active Moisturizing Cream
Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* non-small cell lung cancer * eligible to start treatment with erlotinib
Exclusion criteria
* hypersensitivity to metronidazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | After 2 weeks of metronidazole treatment | 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. |
| Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | After 4 weeks of metronidazole treatment | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevention (Erlotinib + Metronidazole Actavis) Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). | 18 |
| Treatment (Erlotinib + Metronidazole Actavis) Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 2 | 2 |
| Overall Study | Progression or death | 2 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Prevention (Erlotinib + Metronidazole Actavis) | Treatment (Erlotinib + Metronidazole Actavis) | Total |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 10.8 | 70 years STANDARD_DEVIATION 13.1 | 69 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 18 | 1 / 16 |
| serious Total, serious adverse events | 3 / 18 | 5 / 16 |
Outcome results
Primary
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
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.
Time frame: After 2 weeks of metronidazole treatment
Population: All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 3 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 0 (n=9,9,6,6) | 11 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 1 (n=9,9,6,6) | 33 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 1 (n=9,9,6,6) | 33 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 0 (n=9,9,6,6) | 56 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 2 (n=9,9,6,6) | 22 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 2 (n=9,9,6,6) | 11 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 3 (n=9,9,6,6) | 33 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 0 (n=9,9,6,6) | 56 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 3 (n=9,9,6,6) | 22 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 1 (n=9,9,6,6) | 33 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 3 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 0 (n=9,9,6,6) | 22 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 2 (n=9,9,6,6) | 11 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 2 (n=9,9,6,6) | 33 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 1 (n=9,9,6,6) | 22 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 3 (n=9,9,6,6) | 17 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 0 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 0 (n=9,9,6,6) | 33 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 1 (n=9,9,6,6) | 50 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 1 (n=9,9,6,6) | 17 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 2 (n=9,9,6,6) | 33 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 2 (n=9,9,6,6) | 33 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 3 (n=9,9,6,6) | 17 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 2 (n=9,9,6,6) | 17 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 2 (n=9,9,6,6) | 17 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 0 (n=9,9,6,6) | 33 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 1 (n=9,9,6,6) | 17 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 1 (n=9,9,6,6) | 33 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 5 (n=9,9,6,6) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 3 (n=9,9,6,6) | 17 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 3 (n=9,9,6,6) | 17 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Chest Rash: Grade 0 (n=9,9,6,6) | 50 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Facial Rash: Grade 4 (n=9,9,6,6) | 0 percentage of participants |
Primary
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
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.
Time frame: After 4 weeks of metronidazole treatment
Population: All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 4 (n=8,8,4,4) | 13 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 3 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 0 (n=8,8,4,4) | 13 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 4 (n=8,8,4,4) | 13 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 1 (n=8,8,4,4) | 63 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 1 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 0 (n=8,8,4,4) | 75 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 2 (n=8,8,4,4) | 13 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 2 (n=8,8,4,4) | 13 percentage of participants |
| Left Side - Prevention (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 3 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 0 (n=8,8,4,4) | 63 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 3 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 1 (n=8,8,4,4) | 13 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 4 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 4 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 3 (n=8,8,4,4) | 13 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 0 (n=8,8,4,4) | 25 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 2 (n=8,8,4,4) | 13 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 2 (n=8,8,4,4) | 25 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 1 (n=8,8,4,4) | 50 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 3 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 0 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 0 (n=8,8,4,4) | 25 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 1 (n=8,8,4,4) | 50 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 1 (n=8,8,4,4) | 25 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 2 (n=8,8,4,4) | 25 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 2 (n=8,8,4,4) | 25 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 3 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 4 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 4 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Left Side - Treatment (Erlotinib + Standard Procedures) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 2 (n=8,8,4,4) | 25 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 2 (n=8,8,4,4) | 50 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 0 (n=8,8,4,4) | 25 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 4 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 1 (n=8,8,4,4) | 25 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 1 (n=8,8,4,4) | 50 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 5 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 3 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 3 (n=8,8,4,4) | 0 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Chest Rash: Grade 0 (n=8,8,4,4) | 50 percentage of participants |
| Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Facial Rash: Grade 4 (n=8,8,4,4) | 0 percentage of participants |