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The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
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This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA, EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25). Subjects were transferred once the feeder trial (EMR 63325-005 [NCT00157209], EMR 63325-006 [NCT00157196] and EMR 63325-008 [NCT01094548]) objectives were met. Subjects who received tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as were observed for progressive disease (PD) and survival in 6- month intervals. Subjects who had not received tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecemotide (L-BLP25) | Experimental |
| |
| Observational | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecemotide | Biological | Subjects who received tecemotide (L-BLP25) for the treatment of non-small cell lung cancer (NSCLC) or multiple myeloma in a feeder trial will continue to be treated with tecemotide (L-BLP25) and have safety assessments performed until the discontinuation criteria in the respective feeder trial protocol are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is 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, AEs leading to discontinuation and AEs leading to death. | Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive. | From randomization to death, assessed up to 3.6 years |
Not provided
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck KGaA Communication Center | Darmstadt | Germany |
Subjects who participated in the tecemotide (L-BLP25) clinical trials (EMR 63325-005, EMR 63325-006, and EMR 63325-008 served as feeder studies) were considered in this follow-up study after the protocol specific inclusion and exclusion criteria to continue their maintenance treatment. A total of 27 subjects were enrolled in this follow-up study.
First/last subject (informed consent): January 2012/July 2012. Subjects randomized at 9 sites in Canada and Sweden.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Non-small Cell Lung Cancer (NSCLC) | Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide. |
| FG001 | Multiple Myeloma | Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Screening analysis set included all the subjects included in the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-small Cell Lung Cancer (NSCLC) | Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide. |
| 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 | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is 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, AEs leading to discontinuation and AEs leading to death. | Only subjects treated with tecemotide were included in the safety analysis set. | Posted | Number | Subjects | Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years |
|
Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
Not provided
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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 | NSCLC | Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
The study was terminated prematurely as the sponsor decided to discontinue program with Tecemotide in non-small cell lung cancer (NSCLC).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C518273 | L-BLP25 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| No intervention | Other | Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25), will only be observed for progressive disease (PD) (if applicable) and survival in 6-month intervals and will not be provided treatment with tecemotide (L-BLP25). |
|
| BG001 | Multiple Myeloma | Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Multiple Myeloma | Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. |
|
|
| Secondary | Overall Survival (OS) | Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive. | Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115) | Posted | From randomization to death, assessed up to 3.6 years |
|
|
| 8 |
| 12 |
| 12 |
| 12 |
| EG001 | Multiple Myeloma | Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. | 0 | 8 | 7 | 8 |
| Bronchopneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Gingival ulceration | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Oral allergy syndrome | Immune system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Infection parasitic | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Lip infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Mycobacterial infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Nerve injury | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pulmonary radiation injury | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Radiation fibrosis | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Radiation fibrosis - lung | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Troponin I increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Clubbing | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Pulmonary pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
The Investigator will inform the Sponsor in advance about any plans to publish or present data from the trial. Any publications and presentations of the results (abstracts in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require pre-submission review by the Sponsor.The Sponsor will not suppress or veto publications, but maintains the 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 |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |