Trial Outcomes & Findings for A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash. (NCT NCT00718315)
NCT ID: NCT00718315
Last Updated: 2015-01-15
Results Overview
Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash").
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
201 participants
Primary outcome timeframe
30 Days
Results posted on
2015-01-15
Participant Flow
Participant milestones
| Measure |
Fisiogel
Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
67
|
|
Overall Study
COMPLETED
|
48
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
21
|
Reasons for withdrawal
| Measure |
Fisiogel
Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
3
|
|
Overall Study
Death
|
6
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
4
|
|
Overall Study
Protocol Violation
|
5
|
5
|
3
|
|
Overall Study
Erlotinib dose decreased
|
4
|
3
|
1
|
|
Overall Study
Use of Minocyclin
|
1
|
1
|
1
|
|
Overall Study
Disease progression
|
0
|
1
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
|
Overall Study
Use of ATB and Corticoids
|
0
|
1
|
2
|
Baseline Characteristics
A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Baseline characteristics by cohort
| Measure |
Fisiogel
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=67 Participants
Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=67 Participants
Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
63.6 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
64.7 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: ITT Population
Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash").
Outcome measures
| Measure |
Fisiogel
n=65 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=65 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants Who Develop Skin Rash
|
60.0 percentage of participants
Interval 47.1 to 72.0
|
69.2 percentage of participants
Interval 56.6 to 80.1
|
73.1 percentage of participants
Interval 60.9 to 83.2
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: ITT Population
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death
Outcome measures
| Measure |
Fisiogel
n=57 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=60 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=60 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants With Skin Rash Stratified by Severity Grade
Grade 0
|
29.8 percentage of participants
|
25.0 percentage of participants
|
18.3 percentage of participants
|
|
Percentage of Participants With Skin Rash Stratified by Severity Grade
Grade 1
|
21.1 percentage of participants
|
18.3 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants With Skin Rash Stratified by Severity Grade
Grade 2
|
49.1 percentage of participants
|
56.7 percentage of participants
|
35.0 percentage of participants
|
|
Percentage of Participants With Skin Rash Stratified by Severity Grade
Grade 3
|
0 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Skin Rash Stratified by Severity Grade
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Skin Rash Stratified by Severity Grade
Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0, 15, and 30Population: ITT Population
Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE
Outcome measures
| Measure |
Fisiogel
n=65 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=65 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Time to Appearance of Skin Rash
|
16.0 Days
Interval 15.0 to 28.0
|
15.0 Days
Interval 15.0 to 16.0
|
15.0 Days
Interval 14.0 to 15.0
|
SECONDARY outcome
Timeframe: Days 0, 15, and 30Population: ITT Population
Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries
Outcome measures
| Measure |
Fisiogel
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants With Erythema
|
56.7 percentage of participants
Interval 44.8 to 67.9
|
56.7 percentage of participants
Interval 44.8 to 67.9
|
43.3 percentage of participants
Interval 32.1 to 55.2
|
SECONDARY outcome
Timeframe: Days 0, 15, and 30Population: ITT Population
Pruritus is defined as intense localized itching
Outcome measures
| Measure |
Fisiogel
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=63 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants With Pruritus
|
36.1 percentage of participants
Interval 25.2 to 48.6
|
47.6 percentage of participants
Interval 35.8 to 59.7
|
29.5 percentage of participants
Interval 19.6 to 41.9
|
SECONDARY outcome
Timeframe: Days 0, 15, and 30Population: ITT Population
Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli
Outcome measures
| Measure |
Fisiogel
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=67 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants With Pain
|
16.4 percentage of participants
Interval 9.4 to 27.1
|
25.4 percentage of participants
Interval 16.5 to 36.9
|
13.4 percentage of participants
Interval 7.2 to 23.6
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: ITT Population
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Outcome measures
| Measure |
Fisiogel
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=63 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants With Erythema Stratified by Severity Grade
Grade 0
|
37.7 percentage of participants
|
39.7 percentage of participants
|
52.5 percentage of participants
|
|
Percentage of Participants With Erythema Stratified by Severity Grade
Grade 1
|
39.3 percentage of participants
|
36.5 percentage of participants
|
39.3 percentage of participants
|
|
Percentage of Participants With Erythema Stratified by Severity Grade
Grade 2
|
23.0 percentage of participants
|
22.2 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Erythema Stratified by Severity Grade
Grade 3
|
0 percentage of participants
|
1.6 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Erythema Stratified by Severity Grade
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erythema Stratified by Severity Grade
Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: ITT Population
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Outcome measures
| Measure |
Fisiogel
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=63 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants With Pruritus Stratified by Severity Grade
Grade 0
|
63.9 percentage of participants
|
52.4 percentage of participants
|
70.5 percentage of participants
|
|
Percentage of Participants With Pruritus Stratified by Severity Grade
Grade 1
|
19.7 percentage of participants
|
31.7 percentage of participants
|
24.6 percentage of participants
|
|
Percentage of Participants With Pruritus Stratified by Severity Grade
Grade 2
|
14.8 percentage of participants
|
14.3 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Pruritus Stratified by Severity Grade
Grade 3
|
1.6 percentage of participants
|
1.6 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Pruritus Stratified by Severity Grade
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pruritus Stratified by Severity Grade
Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: ITT Population
The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Outcome measures
| Measure |
Fisiogel
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=63 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=61 Participants
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Percentage of Participants With Pain Stratified by Severity Grade
Grade 0
|
82.0 percentage of participants
|
73.0 percentage of participants
|
85.2 percentage of participants
|
|
Percentage of Participants With Pain Stratified by Severity Grade
Grade 1
|
11.5 percentage of participants
|
22.2 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Pain Stratified by Severity Grade
Grade 2
|
4.9 percentage of participants
|
4.8 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Pain Stratified by Severity Grade
Grade 3
|
1.6 percentage of participants
|
0 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Pain Stratified by Severity Grade
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pain Stratified by Severity Grade
Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Fisiogel
Serious events: 12 serious events
Other events: 45 other events
Deaths: 0 deaths
Stiemicyn
Serious events: 13 serious events
Other events: 45 other events
Deaths: 0 deaths
Verutex
Serious events: 19 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fisiogel
n=67 participants at risk
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=66 participants at risk
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=67 participants at risk
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
General disorders
Fatigue (asthenia, lethargy, malaise
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
General disorders
Fever (in the absence of neutropenia, where neurtropenia is defined as ANC <1.0x109/L)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
General disorders
No specification
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death not associated with CTCAE term
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death not associated with CTCAE term - "cardiac arrest"
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Obstruction, GI - small bowel NOS
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
No specification
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Hemorrhage, GI, lower GI NOS
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Hemorrhage, GI, stomach
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory, respiratory tract NOS
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Infections and infestations
Sepsis
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Infections and infestations
Lung (pneumonia)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Infections and infestations
Pulmonary/upper respiratory
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Nervous system disorders
Confusion
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
No specification, pulmonary/upper respiratory, pain
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Vascular disorders
No specification, cardiovascular, pain
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.0%
4/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
No specification
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression NOS
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Vascular disorders
Vessel injury - vein - SVC
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
Other adverse events
| Measure |
Fisiogel
n=67 participants at risk
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Stiemicyn
n=66 participants at risk
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
|
Verutex
n=67 participants at risk
Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
22.4%
15/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
27.3%
18/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
20.9%
14/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Anorexia
|
7.5%
5/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
10.6%
7/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
9.0%
6/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.1%
4/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - oral cavity
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
7.6%
5/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.1%
4/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - oral cavity
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
No specification
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.0%
6/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.1%
4/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.0%
4/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
10.6%
7/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
No specification
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
13.4%
9/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
12.1%
8/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.0%
4/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
General disorders
Fever
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Skin and subcutaneous tissue disorders
No specification
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.0%
4/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Skin and subcutaneous tissue disorders
Nail change
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Infections and infestations
Lung (pneumonia)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Infections and infestations
Pulmonary/upper respiratory
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
6.1%
4/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
9.0%
6/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Infections and infestations
Renal/genitourinary
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Infections and infestations
No specification
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Musculoskeletal and connective tissue disorders
No specification
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
General disorders
No specification
|
4.5%
3/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Nervous system disorders
Dizziness
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death not associated with CTCAE term
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
4.5%
3/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Eye disorders
Dry eye syndrome
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
0.00%
0/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
1.5%
1/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/66 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
3.0%
2/67 • Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER