Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer (NCT NCT00573989)
NCT ID: NCT00573989
Last Updated: 2019-01-03
Results Overview
Dose at which 100% of participants tolerated the dose
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
56 Days
Results posted on
2019-01-03
Participant Flow
Participant milestones
| Measure |
Erlotinib 100mg
Participants will be given 100mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 125mg
Participants will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 150mg
Participants will be given 150mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 125mg- Phase II
Participants in phase II will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
|---|---|---|---|---|
|
Erlotinib Phase I
STARTED
|
4
|
6
|
5
|
0
|
|
Erlotinib Phase I
COMPLETED
|
4
|
6
|
5
|
0
|
|
Erlotinib Phase I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Erlotinib 125mg- Phase II
STARTED
|
0
|
0
|
0
|
12
|
|
Erlotinib 125mg- Phase II
COMPLETED
|
0
|
0
|
0
|
12
|
|
Erlotinib 125mg- Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib
n=27 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
|
Age, Continuous
|
62.96 years
STANDARD_DEVIATION 7.87 • n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 56 DaysDose at which 100% of participants tolerated the dose
Outcome measures
| Measure |
Erlotinib
n=27 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)
|
125 mg
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Data corresponds to Phase II patients.
Determine Progression Free Survival at 1 year defined as the percentage of patients who are alive at 1 year after beginning of their concurrent re-irradiation and chemotherapy without loco-regional progression of their disease as measured by CT scan or MRI.
Outcome measures
| Measure |
Erlotinib
n=12 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Progression-free Survival (PFS) at 1 Year (Phase II)
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data corresponds to Phase II patients.
Median Progression Free Survival of participants reported after 2 years.
Outcome measures
| Measure |
Erlotinib
n=12 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Median Progression Free Survival
|
.71 years
Interval 0.58 to 0.99
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Data corresponds to Phase II patients.
Median Overall Survival of participants reported after 2 years.
Outcome measures
| Measure |
Erlotinib
n=12 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Median Overall Survival
|
1.01 years
Interval 0.65 to 3.08
|
SECONDARY outcome
Timeframe: 1 and 2 yearsPopulation: Data corresponds to Phase II patients.
Overall survival of participants reported after 2 years.
Outcome measures
| Measure |
Erlotinib
n=12 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Overall Survival
1 year
|
9 Participants
|
|
Overall Survival
2 years
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearEvaluate acute and chronic toxicity of the combined re-irradiation with radiosensitizing drugs: Pemetrexed and Erlotinib. Adverse events with Common Toxicity Criteria grades of 4 and 5 are reported for phase I and II.
Outcome measures
| Measure |
Erlotinib
n=25 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Evaluation of Acute and Chronic Toxicity
phase I
|
18 events
|
|
Evaluation of Acute and Chronic Toxicity
phase II
|
6 events
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: Data not collected for all participants at 12 months. Data corresponds to Phase II patients.
The Functional Assessment of Cancer Therapy-Head and Neck (FACT H\&N) consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain. Score range is 0-156. Higher scores denotes better outcomes
Outcome measures
| Measure |
Erlotinib
n=10 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Change in Quality of Life- FACT H&N
baseline
|
84.87 units on a scale
Standard Deviation 8.19
|
|
Change in Quality of Life- FACT H&N
12 months
|
88.61 units on a scale
Standard Deviation 18.64
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Data not collected for all participants.
The Performance Status Scale for Head \& Neck Cancer Patients (PSS-HN) is s designed to evaluate performance in areas of functioning most likely affected by head and neck cancer and its treatment, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated from 0 to 100, with higher scores indicating better performance
Outcome measures
| Measure |
Erlotinib
n=9 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Change in Quality of Life: PSS-HN
Eating Baseline
|
56.25 units on a scale
Standard Deviation 34.72
|
|
Change in Quality of Life: PSS-HN
Eating 6 months
|
43.75 units on a scale
Standard Deviation 23.94
|
|
Change in Quality of Life: PSS-HN
Speech Baseline
|
81.25 units on a scale
Standard Deviation 11.57
|
|
Change in Quality of Life: PSS-HN
Speech 6 months
|
75.0 units on a scale
Standard Deviation 20.41
|
|
Change in Quality of Life: PSS-HN
Diet Baseline
|
44.44 units on a scale
Standard Deviation 44.47
|
|
Change in Quality of Life: PSS-HN
Diet 6 months
|
25.0 units on a scale
Standard Deviation 50.0
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: Data not collected on all participants at 12 months. Data corresponds to Phase II patients.
The M.D. Anderson Dysphagia Inventory (MDADI) was used to assess effects of dysphagia on the quality of life of patients with head and neck cancer. It incorporates 3 domains (emotional, functional, and physical) as well as 1 global question. Each subscale with five possible responses scored on a scale of 1 to 5 (strongly agree, agree, no opinion, disagree and strongly disagree). Scores range from 0 (extremely low functioning) to 100 (higher functioning). Higher MDADI score represents better day-to-day functioning and better quality of life.
Outcome measures
| Measure |
Erlotinib
n=9 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Change in Quality of Life: MDADI
baseline- global
|
64.44 units on a scale
Standard Deviation 26.03
|
|
Change in Quality of Life: MDADI
12 months- global
|
90.0 units on a scale
Standard Deviation 14.14
|
|
Change in Quality of Life: MDADI
baseline- emotion
|
70.37 units on a scale
Standard Deviation 9.2
|
|
Change in Quality of Life: MDADI
12 months- emotion
|
78.33 units on a scale
Standard Deviation 2.36
|
|
Change in Quality of Life: MDADI
baseline- function
|
65.78 units on a scale
Standard Deviation 12.98
|
|
Change in Quality of Life: MDADI
12 months- function
|
84.0 units on a scale
Standard Deviation 5.66
|
|
Change in Quality of Life: MDADI
baseline- physical
|
60.0 units on a scale
Standard Deviation 7.91
|
|
Change in Quality of Life: MDADI
12 months- physical
|
73.75 units on a scale
Standard Deviation 8.84
|
SECONDARY outcome
Timeframe: throughout study completion, up to 2 yearsPopulation: Patients refused biopsy, so no data collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data corresponds to Phase II patients.
Objective Tumor Response reported on participants at 1 year (complete, partial, progression, or stable response).
Outcome measures
| Measure |
Erlotinib
n=12 Participants
Erlotinib
erlotinib hydrochloride
pemetrexed disodium
quality-of-life assessment
intensity-modulated radiation therapy
|
|---|---|
|
Objective Tumor Response
Complete
|
7 Participants
|
|
Objective Tumor Response
Partial
|
5 Participants
|
|
Objective Tumor Response
Progression
|
4 Participants
|
|
Objective Tumor Response
Stable
|
2 Participants
|
Adverse Events
Erlotinib 100 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Erlotinib 125mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Erlotinib 150mg
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Erlotinib 125mg Phase II
Serious events: 5 serious events
Other events: 11 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Erlotinib 100 mg
n=4 participants at risk
Participants will be given 100mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 125mg
n=6 participants at risk
Participants will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 150mg
n=5 participants at risk
Participants will be given 150mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 125mg Phase II
n=11 participants at risk
Participants in phase II will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypoxia
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Immune system disorders
Neutrophils/granulocytes
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
CPK
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Calcium, serum-low
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Cardiac troponin I
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Pain
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Acidosis
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
Other adverse events
| Measure |
Erlotinib 100 mg
n=4 participants at risk
Participants will be given 100mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 125mg
n=6 participants at risk
Participants will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 150mg
n=5 participants at risk
Participants will be given 150mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
Erlotinib 125mg Phase II
n=11 participants at risk
Participants in phase II will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
|
|---|---|---|---|---|
|
General disorders
Pain: Oral-gums
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Scalp
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Hepatobiliary disorders
ALT, SGPT
|
75.0%
3/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Hepatobiliary disorders
AST, SGOT
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
36.4%
4/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Albumin, serum-low
|
75.0%
3/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
100.0%
6/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
100.0%
5/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
72.7%
8/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Alkaline phosphatase
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Immune system disorders
Allergic rhinitis
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Bilirubin
|
75.0%
3/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
45.5%
5/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Calcium, serum-low
|
75.0%
3/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
100.0%
5/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
81.8%
9/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Cardiac General
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Musculoskeletal and connective tissue disorders
Cervical spine
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
45.5%
5/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Cough
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
36.4%
4/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Creatinine
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Dehydration
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
54.5%
6/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
72.7%
8/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Dizziness
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Eye disorders
Dry eye syndrome
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Dry mouth/salivary gland
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Dysphagia
|
75.0%
3/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
63.6%
7/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Edema
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Esophagitis
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Eye disorders
Eyelid dysfunction
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Fatigue
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
72.7%
8/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Fever
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Fistula, GI
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Glucose, serum-high
|
75.0%
3/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
83.3%
5/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
90.9%
10/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Glucose, serum-low
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Ear and labyrinth disorders
Hearing
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
4/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
100.0%
6/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
90.9%
10/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Hypertension
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Hypotension
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Nervous system disorders
Insomnia
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Leukocytes
|
100.0%
4/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
90.9%
10/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Lymphedema-related fibrosis
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
4/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
100.0%
6/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
90.9%
10/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Renal and urinary disorders
Magnesium, serum-high
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Renal and urinary disorders
Magnesium, serum-low
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
45.5%
5/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Nervous system disorders
Mood alteration
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Mucositis/stomatitis (clinical exam)
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
81.8%
9/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
83.3%
5/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
72.7%
8/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Immune system disorders
Neutrophils/granulocytes
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
45.5%
5/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Musculoskeletal and connective tissue disorders
Pain: Abdomen NOS
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Chest/thorax NOS
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Eye disorders
Pain: Eye
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Head/headache
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Neck
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Oral cavity
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Pain: Stomach
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Throat/pharynx/larynx
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Phosphate, serum-low
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Platelets
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
63.6%
7/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Potassium, serum-high (hyperkalemia) (3.5-5.3)
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
45.5%
5/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Potassium, serum-low (hypokalemia) (3.5-5.3)
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
75.0%
3/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
80.0%
4/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
36.4%
4/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
45.5%
5/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation: Chemoradiation
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation: Radiation
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
83.3%
5/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
36.4%
4/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Rigors/chills
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Renal and urinary disorders
Sodium, serum-high
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
27.3%
3/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Renal and urinary disorders
Sodium, serum-low
|
100.0%
4/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
66.7%
4/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
63.6%
7/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus bradycardia
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus tachycardia
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Trismus (difficulty, restriction or pain when opening mouth)
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Eye disorders
Vision-flashing lights/floaters
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
36.4%
4/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Weight loss
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
18.2%
2/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Bone
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
4/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Edema: limb
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Pharynx
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Stoma
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Trachea
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Hemorrhage/Bleeding - Other
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Hypoxia
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
9.1%
1/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Trachea
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Vagina
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with unknown ANC: Conjunctiva
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with unknown ANC: Lip/perioral
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with unknown ANC: Skin (cellulitis)
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with unknown ANC: Vagina
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
60.0%
3/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Partial Thromboplastin Time
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Back
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Cardiac/heart
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Chest wall
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: External ear
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Face
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Joint
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Middle ear
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Pleura
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Skin
|
50.0%
2/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Tumor pain
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Salivary gland changes/saliva
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
50.0%
3/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Tumor flare
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Vascular disorders
Vessel injury-vein: Extremity-upper
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Vascular disorders
Vessel injury-vein: IVC
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Alkalosis (metabolic or respiratory) (7.35-7.45)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Calcium, ionized-low (hypocalcemia)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Cholesterol, serum-high (hypercholesteremia) (<200)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Confusion
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Hepatobiliary disorders
Gamma-Glutamyl transpeptidase
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Renal and urinary disorders
Glomerular filtration rate
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Hemorrhage, GI: Lower GI NOS
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Hemorrhage, GU: Stoma
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Bronchus
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection (Doc.) with Grade 3/4 ANC: Eye NOS
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Mood alteration: Agitation
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain - Other
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Bone
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Extremity-limb
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Pain: Pain NOS
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Taste alteration (dysgeusia)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Ventricular arrhythmia: Ventricular tachycardia
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Wound complication, non-infectious
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Bicarbonate, serum-low
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
General disorders
Hemorrhoids
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Gastrointestinal disorders
Ileus, GI
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Renal and urinary disorders
Proteinuria (neg, trace)
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
16.7%
1/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
40.0%
2/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
25.0%
1/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
33.3%
2/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Blood and lymphatic system disorders
Lymphatics
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
|
Eye disorders
Ocular/Visual - Other
|
0.00%
0/4 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/6 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
20.0%
1/5 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
0.00%
0/11 • up to 5 years
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
|
Additional Information
Dr. Mercedes Porosnicu
Wake Forest University Health Sciences
Phone: 336-716-8664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place