Trial Outcomes & Findings for An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer (NCT NCT01161173)
NCT ID: NCT01161173
Last Updated: 2016-03-28
Results Overview
The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR.
Recruitment status
COMPLETED
Target enrollment
347 participants
Primary outcome timeframe
Baseline to the end of the study (up to 4 years, 4 months)
Results posted on
2016-03-28
Participant Flow
Participant milestones
| Measure |
Erlotinib
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
|
|---|---|
|
Overall Study
STARTED
|
347
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
347
|
Reasons for withdrawal
| Measure |
Erlotinib
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
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|---|---|
|
Overall Study
Protocol Violation
|
13
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Progressive Disease
|
82
|
|
Overall Study
Withdrawal of Consent
|
5
|
|
Overall Study
Unacceptable Toxicity
|
21
|
|
Overall Study
Death
|
194
|
|
Overall Study
End of Study
|
2
|
|
Overall Study
Reasons Not Specified
|
23
|
Baseline Characteristics
An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cohort
n=334 Participants
Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate.
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|---|---|
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Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 4 months)Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.
The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR.
Outcome measures
| Measure |
Erlotinib
n=249 Participants
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
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|---|---|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Complete response
|
0.8 Percentage of participants
Interval 0.1 to 2.9
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Stable disease
|
48.2 Percentage of participants
Interval 41.7 to 54.6
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Progressive disease
|
47.3 Percentage of participants
Interval 41.0 to 53.8
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Partial response
|
3.7 Percentage of participants
Interval 1.7 to 6.9
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 4 months)Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.
The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Erlotinib
n=334 Participants
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
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|---|---|
|
Time to Disease Progression
|
3.6 Months
Interval 3.0 to 4.4
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 4 months)Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.
Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Erlotinib
n=334 Participants
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
|
|---|---|
|
Progression-free Survival
|
2.7 Months
Interval 2.5 to 3.0
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 4 months)Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.
Overall survival was defined as the time from Baseline until or death from any cause
Outcome measures
| Measure |
Erlotinib
n=334 Participants
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
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|---|---|
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Overall Survival
|
7.1 Months
Interval 5.1 to 9.5
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 4 months)Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with LCSS scores were included in the analysis.
Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic \[cough, dyspnea, haemoptysis\] and 3 general symptoms \[loss of appetite, fatigue, pain\]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.
Outcome measures
| Measure |
Erlotinib
n=298 Participants
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
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|---|---|
|
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
Patient SBI (n=283)
|
0.15 Units on a scale
Interval 0.003 to 0.306
|
|
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
Patient total score (n=283)
|
0.20 Units on a scale
Interval 0.02 to 0.37
|
|
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
Physician SBI (n=298)
|
-0.09 Units on a scale
Interval -0.21 to -0.021
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 4 months)Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.
At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.
Outcome measures
| Measure |
Erlotinib
n=334 Participants
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
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|---|---|
|
Percentage of Participants Who Developed Rash
|
63.5 Percentage of participants
Interval 58.0 to 69.0
|
Adverse Events
Erlotinib
Serious events: 210 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=347 participants at risk
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
Erlotinib: Erlotinib was provided in the retail versions of the product.
|
|---|---|
|
General disorders
Systemic inflammatory response syndrome
|
0.86%
3/347 • Number of events 3
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Bronchitis bacterial
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Infection
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
16/347 • Number of events 16
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Pain
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Asthenia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Pyrexia
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Chest pain
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Disease progression
|
24.5%
85/347 • Number of events 85
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Fatigue
|
1.2%
4/347 • Number of events 4
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
General physical health deterioration
|
5.5%
19/347 • Number of events 19
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Death
|
5.5%
19/347 • Number of events 19
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
General disorders
Oedema peripheral
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Cardiac disorders
Palpitations
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Eye disorders
Dry eye
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Eye disorders
Eye disorder
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.86%
3/347 • Number of events 3
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.86%
3/347 • Number of events 3
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Listeria sepsis
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Localised infection
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Lung infection
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Pneumonia
|
2.0%
7/347 • Number of events 7
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Postoperative wound infection
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Sepsis
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Investigations
C-reactive protein increased
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Investigations
General physical condition abnormal
|
1.2%
4/347 • Number of events 4
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Investigations
Liver function test abnormal
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Investigations
Weight decreased
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
7/347 • Number of events 7
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Nervous system disorders
Coma
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Nervous system disorders
Epilepsy
|
0.86%
3/347 • Number of events 3
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Nervous system disorders
Loss of consciousness
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Nervous system disorders
Nervous system disorder
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Nervous system disorders
Paraesthesia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.86%
3/347 • Number of events 3
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
12/347 • Number of events 12
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
5/347 • Number of events 5
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.86%
3/347 • Number of events 3
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.86%
3/347 • Number of events 3
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.58%
2/347 • Number of events 2
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
18/347 • Number of events 18
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Vascular disorders
Aortic thrombosis
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.29%
1/347 • Number of events 1
Safety analysis population: All participants who received at least 1 dose of erlotinib. The seriousness of adverse events was not captured in this observational study, therefore, all adverse events are reported as serious adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER