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This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.
Study Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afatinib | Drug | 50, 40, 30 or 20 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Rate After 12 Months | 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. | After 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. | From the initial dose of study drug until end of the treatment period, up to 48 months. |
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Inclusion criteria:
Exclusion criteria:
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NSCLC-EGFR mutation positive
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36323612 | Derived | Brueckl WM, Reck M, Schafer H, Neben K, Griesinger F, Rawluk J, Kruger S, Kokowski K, Ficker JH, Moller M, Schueler A, Laack E. Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study. J Geriatr Oncol. 2023 Jan;14(1):101394. doi: 10.1016/j.jgo.2022.10.009. Epub 2022 Oct 30. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): This patient set included all patients who received at least one dose of afatinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) Rate After 12 Months | 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. | 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. | Posted | Number | 95% Confidence Interval | Percent probability of PFS | After 12 months |
|
From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2017 | Dec 18, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 1, 2014 | Dec 18, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
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Not provided
Not provided
Not provided
| Disease Control Rate (DCR) | 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 | From the initial dose of study drug until end of the treatment period, up to 48 months. |
| Progression Free Survival (PFS) | 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. | From first administration of the trial drug until objective tumour progression or death, up to 48 months. |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). | From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. |
| Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia | 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. | From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. |
| Treatment Duration | Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration. | From the initial dose of study drug until end of the treatment period, up to 48 months. |
| Symptom Control - Time to Worsening (Cough, Dyspnea and Pain) | 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. | Up to 48 months |
| Percentage of Participants With Treatment Modification | Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification. | From the initial dose of study drug until end of the treatment period, up to 48 months. |
| Lost to Follow-up |
|
| Reason not listed |
|
| Not Treated |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Objective Response Rate (ORR) | 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. | PPS | Posted | Number | 95% Confidence Interval | Percentage of participants | From the initial dose of study drug until end of the treatment period, up to 48 months. |
|
|
|
| Secondary | Disease Control Rate (DCR) | 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 | PPS | Posted | Number | 95% Confidence Interval | Percentage of participants | From the initial dose of study drug until end of the treatment period, up to 48 months. |
|
|
|
| Secondary | Progression Free Survival (PFS) | 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. | PPS | Posted | Median | 95% Confidence Interval | Months | From first administration of the trial drug until objective tumour progression or death, up to 48 months. |
|
|
|
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). | Treated set (TS): This patient set included all patients who received at least one dose of afatinib. | Posted | Number | Percentage of participants | From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. |
|
|
|
| Secondary | Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia | 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. | TS | Posted | Number | Percentage of participants | From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. |
|
|
|
| Secondary | Treatment Duration | Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration. | TS | Posted | Median | Full Range | Days | From the initial dose of study drug until end of the treatment period, up to 48 months. |
|
|
|
| Secondary | Symptom Control - Time to Worsening (Cough, Dyspnea and Pain) | 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. | TS | Posted | Median | 95% Confidence Interval | Months | Up to 48 months |
|
|
|
| Secondary | Percentage of Participants With Treatment Modification | Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification. | TS | Posted | Number | Percentage of participants | From the initial dose of study drug until end of the treatment period, up to 48 months. |
|
|
|
| 73 |
| 152 |
| 65 |
| 152 |
| 144 |
| 152 |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Mitral valve disease | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pneumobilia | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Dermatitis acneiform |
|
| Acne |
|
| Dry skin |
|
| Pruritus |
|
| Rash |
|
| Rash maculo-papular |
|
| Rash pustular |
|
|
| Pain |
|
|
| Title | Measurements |
|---|---|
|