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This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycline | Drug | 100mg po daily |
| |
| erlotinib [Tarceva] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment | Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment | A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antibes | 06600 | France | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib Plus (+) Doxycycline | Participants received erlotinib 150 milligrams per day (mg/day), tablets, orally (PO) until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
150mg po daily |
|
A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust. |
| Days 0, 14, 28 and Months 2, 3, and 4 |
| Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity | Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment | Months 7, 10, and 12 |
| Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment | A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules. | Months 7, 10, and 12 |
| Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type | A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust. | Months 7, 10, and 12 |
| Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity | Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation. | Months 7, 10, and 12 |
| Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Percentage of Participants Estimated to be Event Free at 4 Months | Percentage of participants estimated to be without skin rash (folliculitis) at 4 months. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Percentage of Participants Estimated to be Event Free at 12 Months | Percentage of participants estimated to be without skin rash (folliculitis) at 12 months. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment | If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Duration of Skin Rash (Folliculitis) During the Whole Treatment Period | If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment | Other skin lesions included presence or absence of xerosis and paronychia. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type | Other skin lesions included xerosis and paronychia. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity | Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account. | Days 0, 14, 28 and Months 2, 3, and 4 |
| Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction | Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction | Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator's opinion. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Percentage of Participants With Global Disease Control by Visit | Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD). | Months 2, 4, 7, 10, and 12 |
| Percentage of Participants by Best Global Response Under Treatment | Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Progression-Free Survival (PFS) - Time to Event | PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Percentage of Participants Estimated to be Progression Free at 4 and 12 Months | Months 4 and 12 |
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Overall Survival (OS) - Time to Event | OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method. | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
| Percentage of Participants Estimated to be Alive at 4 and 12 Months | Months 4 and 12 |
| Dermatology Life Quality Index (DLQI) Global Score | Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined. | Baseline, Days 14 and 28 and Months 2, 3, and 4 |
| Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life | Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect). | Baseline, Days 14 and 28 and Months 2, 3, and 4 |
| Quality of Life Score as Assessed by Visual Analog Scale (VAS) | Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint). | Baseline, Days 14 and 28, and Months 2, 3, and 4 |
| Bordeaux |
| 33076 |
| France |
| Bordeaux | 33300 | France |
| Brest | 29200 | France |
| Caen | 14076 | France |
| Chalon-sur-Saône | 71100 | France |
| Chartres | 28018 | France |
| Draguignan | 83007 | France |
| Gap | 05007 | France |
| Gleizé | 69400 | France |
| Limoges | 87042 | France |
| Metz | 57038 | France |
| Nîmes | 30900 | France |
| Paris | 75116 | France |
| Paris | 75674 | France |
| Paris | 75679 | France |
| Perpignan | 66000 | France |
| Périgueux | 24000 | France |
| Pierre-Bénite | 69495 | France |
| Pontoise | 95300 | France |
| Rennes | 35033 | France |
| Rouen | 76000 | France |
| Tours | 37044 | France |
| Vannes | 56017 | France |
| Erlotinib |
Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat population (ITT): all randomized participants who received at least
1 dose of erlotinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib + Doxycycline | Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline. |
| BG001 | Erlotinib | Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment | Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation. | ITT population; data for 1 participant in the erlotinib treatment group were missing. | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, and 4 |
|
|
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| Secondary | Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment | A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules. | ITT population | Posted | Number | rash events | Days 0, 14, 28 and Months 2, 3, and 4 |
|
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| Secondary | Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type | A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust. | ITT population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity | Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation. | ITT population; only participants with an adverse event of skin rash (folliculitis) during the first 4 months were included in the analysis. | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment | ITT population | Posted | Number | percentage of participants | Months 7, 10, and 12 |
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| Secondary | Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment | A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules. | ITT population | Posted | Number | rash events | Months 7, 10, and 12 |
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| Secondary | Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type | A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust. | ITT population | Posted | Number | participants | Months 7, 10, and 12 |
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| Secondary | Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity | Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation. | ITT population | Posted | Number | participants | Months 7, 10, and 12 |
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| Secondary | Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | ITT population | Posted | Number | participants | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | ITT population | Posted | Median | 95% Confidence Interval | days | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Percentage of Participants Estimated to be Event Free at 4 Months | Percentage of participants estimated to be without skin rash (folliculitis) at 4 months. | ITT population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | ITT population | Posted | Number | participants | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event | Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. | ITT population | Posted | Median | 95% Confidence Interval | days | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Percentage of Participants Estimated to be Event Free at 12 Months | Percentage of participants estimated to be without skin rash (folliculitis) at 12 months. | ITT population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment | If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death. | ITT Population; only participants with an event (folliculitis) were included in the analysis. | Posted | Mean | Standard Deviation | days | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Duration of Skin Rash (Folliculitis) During the Whole Treatment Period | If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date. | ITT Population; only participants with an event (folliculitis) were included in the analysis. | Posted | Median | Standard Deviation | days | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment | Other skin lesions included presence or absence of xerosis and paronychia. | ITT population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type | Other skin lesions included xerosis and paronychia. | ITT population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity | Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account. | ITT population; only participants with an adverse event classified as other skin lesion during the first 4 months were included in the analysis. | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, and 4 |
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| Secondary | Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction | Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg. | ITT population; only participants that discontinued or interrupted erlotinib were included in the analysis. | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction | Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator's opinion. | ITT population; only participants that discontinued or interrupted doxycycline were included in the analysis. | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Percentage of Participants With Global Disease Control by Visit | Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD). | ITT population; number (n) = number of participants analyzed for the specified parameter at a given visit. | Posted | Number | percentage of participants | Months 2, 4, 7, 10, and 12 |
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| Secondary | Percentage of Participants by Best Global Response Under Treatment | Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported. | ITT Population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method. | ITT Population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Progression-Free Survival (PFS) - Time to Event | PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method. | ITT Population | Posted | Median | 95% Confidence Interval | days | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
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| Secondary | Percentage of Participants Estimated to be Progression Free at 4 and 12 Months | ITT Population | Posted | Number | percentage of participants | Months 4 and 12 |
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| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method. | ITT Population | Posted | Number | percentage of participants | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
|
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| Secondary | Overall Survival (OS) - Time to Event | OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method. | ITT Population | Posted | Median | 95% Confidence Interval | days | Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Estimated to be Alive at 4 and 12 Months | ITT Population | Posted | Number | percentage of participants | Months 4 and 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dermatology Life Quality Index (DLQI) Global Score | Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 14 and 28 and Months 2, 3, and 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life | Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect). | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Number | percentage of participants | Baseline, Days 14 and 28 and Months 2, 3, and 4 |
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| Secondary | Quality of Life Score as Assessed by Visual Analog Scale (VAS) | Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint). | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mm | Baseline, Days 14 and 28, and Months 2, 3, and 4 |
|
Adverse events (AEs) were recorded continuously until 30 days after the last treatment administration.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib + Doxycycline | Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline. | 18 | 73 | 71 | 73 | ||
| EG001 | Erlotinib | Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity. | 24 | 74 | 69 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Folliculitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Xerosis | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Folliculitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Paronychia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aerophagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gingival hypertrophy | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Xerosis | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Catheter site inflammation | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Central line infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Growth of eyelashes | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Visual distrubance | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Laryngeal disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aphonia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Epiduritis | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Facial neuralgia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Parosmia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Periphlebitis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cytolytic hepatitis | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Eschar | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
|
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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