Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003760-30 | EudraCT Number |
Not provided
Not provided
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC
Not provided
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Not provided
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This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecemotide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecemotide | Drug | Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects. | Time from date of randomization until death, assessed maximum up to 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Symptom Progression (TTSP) | TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks. |
Not provided
Inclusion Criteria:
Written informed consent, before any trial-related activities are carried out
Histologically or cytologically documented unresectable stage III NSCLC, including bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scan
Prior concurrent CRT which is defined as follows:
Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary CRT are eligible.
Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol
Male or female, greater than or equal to 18 years of age
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
Not provided
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact U.S. Medical Information Located in | Rockland | Massachusetts | United States | |||
| Please contact the Merck KGaA Communication Center Located in |
50 subjects were screened for eligibility; 15 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 35 subjects were randomized. Three subjects were randomized but were not treated.
First/last subject(informed consent): 21 Mar 2014/11 Sep 2014. Study completion date: 02 Jul 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tecemotide (L-BLP25) + Cyclophosphamide | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented. |
| FG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tecemotide (L-BLP25) + Cyclophosphamide | Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Overall Survival | Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects. | Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline. Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115). | Posted | Number | subjects | Time from date of randomization until death, assessed maximum up to 16 months |
|
Time from first dosing day until 42 days following the last vaccination of tecemotide (L-BLP25) or placebo assessed maximum up to 16 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tecemotide (L-BLP25) + Cyclophosphamide | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA18.0 | Non-systematic Assessment |
Sponsor discontinued development of tecemotide (L-BLP25) in NSCLC, hence the study was terminated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Centre | Merck Serono, a division of Merck KGaA | 496151725200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C518273 | L-BLP25 |
| D003520 | Cyclophosphamide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression. |
|
| Cyclophosphamide (CPA) | Drug | CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide. |
|
| Saline (sodium chloride) | Drug | Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent [%] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo. |
|
| Time from date of randomization until progressive disease (PD), assessed up to 16 months |
| Progression Free Survival (PFS) | PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment. | Time from date of randomization until PD or death, assessed up to 16 months |
| Time to Progression (TTP) | TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death. | Time from date of randomization until PD, assessed up to 16 months |
| Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs) | An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI-CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported. | Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months |
| Darmstadt |
| Germany |
| BG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented. |
| BG002 | Total Title |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented. |
|
|
| Secondary | Time to Symptom Progression (TTSP) | TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks. | Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115). | Posted | Time from date of randomization until progressive disease (PD), assessed up to 16 months |
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment. | Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115). | Posted | Time from date of randomization until PD or death, assessed up to 16 months |
|
|
| Secondary | Time to Progression (TTP) | TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death. | Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115). | Posted | Time from date of randomization until PD, assessed up to 16 months |
|
|
| Secondary | Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs) | An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI-CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported. | Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline. | Posted | Number | subjects | Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months |
|
|
|
| 4 |
| 15 |
| 14 |
| 15 |
| EG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented. | 1 | 17 | 13 | 17 |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Injection site hypoaesthesia | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA18.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA18.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA18.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA18.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA18.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA18.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA18.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA18.0 | Non-systematic Assessment |
|
The first publication will be publication of results of the analysis of primary endpoint(s) that will include data from all trial centers. Any publications and presentations of results, either in whole or in part, by investigators or their representatives will require pre-submission review by the sponsor/CRO. Sponsor will not suppress or veto publications, but maintains right to delay publication in order to protect intellectual property rights.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Grade 3 or 4 TEAEs |
|
| TEAEs Leading to Permanent Discontinuation |
|
| TEAEs leading to death |
|
| ISRs |
|