Trial Outcomes & Findings for GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations (NCT NCT02047903)
NCT ID: NCT02047903
Last Updated: 2020-01-09
Results Overview
The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.
Recruitment status
COMPLETED
Target enrollment
161 participants
Primary outcome timeframe
After 12 months
Results posted on
2020-01-09
Participant Flow
This is a non-interventional study (NIS) in real life clinical setting, in which responses were determined by using Response Evaluation Criteria in Solid Tumors (RECIST)/World Health Organization (WHO)/clinical evidence as investigators deemed appropriate.
Data source for this study were medical records usually collected during routine clinical practice other than study-specific questionnaires. Data collection was performed between March 24, 2014 and March 14, 2019.
Participant milestones
| Measure |
Afatinib
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Overall Study
STARTED
|
161
|
|
Overall Study
Treated
|
152
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
59
|
Reasons for withdrawal
| Measure |
Afatinib
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Serious adverse event
|
10
|
|
Overall Study
Withdrawal by Subject
|
16
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Reason not listed
|
6
|
|
Overall Study
Not Treated
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Afatinib
n=152 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Age, Continuous
|
66.32 Years
STANDARD_DEVIATION 10.70 • n=152 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=152 Participants
|
PRIMARY outcome
Timeframe: After 12 monthsPopulation: Per protocol set (PPS): This set included all patients who gave their informed consent, did not violate any inclusion or exclusion criterion and have at least one documented administration of afatinib.
The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.
Outcome measures
| Measure |
Afatinib
n=146 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Progression Free Survival (PFS) Rate After 12 Months
|
50.24 Percent probability of PFS
Interval 41.55 to 58.29
|
SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the treatment period, up to 48 months.Population: PPS
Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response. Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.
Outcome measures
| Measure |
Afatinib
n=146 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Objective Response Rate (ORR)
|
74.58 Percentage of participants
Interval 65.74 to 82.14
|
SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the treatment period, up to 48 months.Population: PPS
Percentage of participants with controlled disease (CR + PR + stable disease (SD)) as best unconfirmed response. CR, PR and SD were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate
Outcome measures
| Measure |
Afatinib
n=146 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Disease Control Rate (DCR)
|
91.53 Percentage of participants
Interval 84.97 to 95.86
|
SECONDARY outcome
Timeframe: From first administration of the trial drug until objective tumour progression or death, up to 48 months.Population: PPS
PFS was measured from start of therapy until progression or death, whichever came first. Progression was defined as the minimum of the first examination with progression and the date of progression documented by the treating physician. One day was added to the corresponding date. Patients without documented progression and not known to have died were censored at their date of last examination and one day was added. Median was derived by Kaplan Meier methods.
Outcome measures
| Measure |
Afatinib
n=146 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Progression Free Survival (PFS)
|
12.17 Months
Interval 10.46 to 15.99
|
SECONDARY outcome
Timeframe: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.Population: Treated set (TS): This patient set included all patients who received at least one dose of afatinib.
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
Outcome measures
| Measure |
Afatinib
n=152 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
AEs
|
96.05 Percentage of participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
42.76 Percentage of participants
|
SECONDARY outcome
Timeframe: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.Population: TS
Toxicity and side-effect profile: incidence of diarrhea, skin reactions, stomatitis and paronychia. Skin reactions: acne, dermatitis acneiform, dry skin, pruritus, rash, rash maculo-papular, rash pustular.
Outcome measures
| Measure |
Afatinib
n=152 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Rash pustular
|
6.58 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Diarrhea
|
82.89 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Stomatitis
|
18.42 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Paronychia
|
25.66 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Dermatitis acneiform
|
37.50 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Acne
|
1.32 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Dry skin
|
16.45 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Pruritus
|
10.53 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Rash
|
5.26 Percentage of participants
|
|
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Rash maculo-papular
|
17.76 Percentage of participants
|
SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the treatment period, up to 48 months.Population: TS
Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration.
Outcome measures
| Measure |
Afatinib
n=152 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Treatment Duration
|
324.5 Days
Interval 13.0 to 1460.0
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: TS
Symptom control was evaluated for cough, dyspnea and pain. Time to deterioration was calculated from date of baseline European Organisation for Research and Treatment of Cancer (EORTC) questionnaire until date of the EORTC questionnaire, where the first deterioration was measured. Patients without deterioration were censored at their date of last answered EORTC questionnaire, where the corresponding scale is evaluable. Participants had to select one answer on a scale ranging from 1=Not at All to 4=Very Much for questions 1 to 28 and 31 to 43 and on scale ranging from 1=Very Bad to 7=Excellent for questions 29 and 30. Afterwards, these scale scores were linearly transformed such that all scales ranged from 0 to 100, where higher scores represented higher level of symptoms.
Outcome measures
| Measure |
Afatinib
n=152 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)
Cough
|
33.85 Months
Interval 17.86 to
The upper limit was not reached
|
|
Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)
Dyspnea
|
22.17 Months
Interval 13.68 to
The upper limit was not reached
|
|
Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)
Pain
|
18.26 Months
Interval 9.21 to 23.72
|
SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the treatment period, up to 48 months.Population: TS
Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.
Outcome measures
| Measure |
Afatinib
n=152 Participants
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Percentage of Participants With Treatment Modification
Any dose reduction
|
59.87 Percentage of participants
|
|
Percentage of Participants With Treatment Modification
Dose increase
|
17.11 Percentage of participants
|
|
Percentage of Participants With Treatment Modification
Any dose modifications
|
61.84 Percentage of participants
|
Adverse Events
Afatinib
Serious events: 65 serious events
Other events: 144 other events
Deaths: 73 deaths
Serious adverse events
| Measure |
Afatinib
n=152 participants at risk
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Cardiac disorders
Cardiac failure
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Cardiac disorders
Mitral valve disease
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Eye disorders
Cataract
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Eye disorders
Vision blurred
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Diarrhea
|
14.5%
22/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Ileus
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
4/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
General disorders
Chest pain
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
General disorders
Death
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
General disorders
General physical health deterioration
|
2.0%
3/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
General disorders
Pyrexia
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Hepatobiliary disorders
Pneumobilia
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Arthritis infective
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Biliary tract infection
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Cystitis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Enteritis infectious
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Intervertebral discitis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Lung infection
|
2.6%
4/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Osteomyelitis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Sepsis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Skin infection
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Soft tissue infection
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Viral infection
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Investigations
Amylase increased
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Investigations
Blood creatinine increased
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Investigations
Lipase increased
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
4/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Nervous system disorders
Dizziness
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Nervous system disorders
Dysarthria
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Nervous system disorders
Hemiparesis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Nervous system disorders
Seizure
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Psychiatric disorders
Depression
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
3/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Renal and urinary disorders
Renal colic
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Renal and urinary disorders
Renal failure
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
5/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.6%
7/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.3%
2/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Surgical and medical procedures
Spinal operation
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Vascular disorders
Embolism
|
3.3%
5/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Vascular disorders
Hypertensive crisis
|
0.66%
1/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
Other adverse events
| Measure |
Afatinib
n=152 participants at risk
Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
12/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Diarrhea
|
80.9%
123/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Nausea
|
13.2%
20/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Stomatitis
|
18.4%
28/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
13/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
General disorders
Fatigue
|
15.1%
23/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
General disorders
Influenza like illness
|
5.3%
8/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Nail infection
|
6.6%
10/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Paronychia
|
27.6%
42/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Infections and infestations
Rash pustular
|
6.6%
10/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Investigations
Weight decreased
|
5.9%
9/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.2%
11/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
8/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
9/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.8%
24/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
38.2%
58/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
5.3%
8/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.4%
28/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
16/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
8/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.8%
27/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.3%
8/152 • From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER