Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003415-31 | EudraCT Number | ||
| U1111-1123-3503 | Other Identifier | UTN |
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Primary Objective:
To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.
Secondary Objectives:
Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.
All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel | Experimental |
| |
| Topotecan | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel | Drug | Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression. | Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve. | From randomization to date of death (maximum 15 months) |
Not provided
Inclusion criteria :
Exclusion criteria:
Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study
More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes
Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)
Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization
Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
Participants with known leptomeningeal metastases
History of other, invasive neoplasm requiring ongoing therapy
Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack
Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results
Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation
History of hypersensitivity to polysorbate 80
Inadequate organ and bone marrow function as evidenced by:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840007 | Muscle Shoals | Alabama | 35661 | United States | ||
| Investigational Site Number 840005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30537991 | Derived | Beaumont H, Evans TL, Klifa C, Guermazi A, Hong SR, Chadjaa M, Monostori Z. Discrepancies of assessments in a RECIST 1.1 phase II clinical trial - association between adjudication rate and variability in images and tumors selection. Cancer Imaging. 2018 Dec 11;18(1):50. doi: 10.1186/s40644-018-0186-0. | |
| 26200278 | Derived |
Not provided
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A total of 232 participants were screened of which 53 were screen failure and 179 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cabazitaxel | Cabazitaxel (XRP6258) 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. |
| FG001 | Topotecan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
Not provided
Not provided
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|
| Topotecan | Drug | Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent. |
|
| Progression Free Rate at Week 12 | Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported. | Week 12 |
| Overall Objective Tumor Response Rate | Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported. | Randomization to disease progression/occurrence (maximum 7.6 months) |
| Omaha |
| Nebraska |
| 68114 |
| United States |
| Investigational Site Number 840006 | Lebanon | New Hampshire | 03756 | United States |
| Investigational Site Number 840003 | Middletown | Ohio | 45042 | United States |
| Investigational Site Number 840001 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Site Number 076001 | Porto Alegre | 90610-000 | Brazil |
| Investigational Site Number 124003 | Montreal | H3T 1E2 | Canada |
| Investigational Site Number 124002 | Oshawa | L1G 2B9 | Canada |
| Investigational Site Number 124004 | Rimouski | G5L 5T1 | Canada |
| Investigational Site Number 124001 | Toronto | M5G 2M9 | Canada |
| Investigational Site Number 152001 | Santiago | 8380456 | Chile |
| Investigational Site Number 152005 | Santiago | Chile |
| Investigational Site Number 250005 | Brest | 29609 | France |
| Investigational Site Number 250004 | Caen | 14033 | France |
| Investigational Site Number 250006 | La Tronche | 38700 | France |
| Investigational Site Number 250002 | Lille | 59800 | France |
| Investigational Site Number 250003 | Saint-Herblain | 44805 | France |
| Investigational Site Number 250007 | Villejuif | 94805 | France |
| Investigational Site Number 276003 | Großhansdorf | 22927 | Germany |
| Investigational Site Number 276006 | Löwenstein | 74245 | Germany |
| Investigational Site Number 300005 | Athens | 11522 | Greece |
| Investigational Site Number 300003 | Athens | 11527 | Greece |
| Investigational Site Number 300001 | Heraklion | 71110 | Greece |
| Investigational Site Number 300002 | Thessaloniki | 54629 | Greece |
| Investigational Site Number 300004 | Thessaloniki | 57010 | Greece |
| Investigational Site Number 348001 | Budapest | 1121 | Hungary |
| Investigational Site Number 348004 | Budapest | 1121 | Hungary |
| Investigational Site Number 348002 | Budapest | 1125 | Hungary |
| Investigational Site Number 348003 | Törökbálint | 2045 | Hungary |
| Investigational Site Number 380001 | Genova | 16132 | Italy |
| Investigational Site Number 380002 | Livorno | 57123 | Italy |
| Investigational Site Number 380005 | Novara | 28100 | Italy |
| Investigational Site Number 380004 | Parma | 43100 | Italy |
| Investigational Site Number 578001 | Oslo | 0440 | Norway |
| Investigational Site Number 578003 | Stavanger | 4011 | Norway |
| Investigational Site Number 578002 | Trondheim | 7006 | Norway |
| Investigational Site Number 616004 | Gdansk | 80-952 | Poland |
| Investigational Site Number 616003 | Lublin | 20-954 | Poland |
| Investigational Site Number 616002 | Poznan | 60-569 | Poland |
| Investigational Site Number 616001 | Warsaw | 02-781 | Poland |
| Investigational Site Number 642003 | Cluj-Napoca | 400015 | Romania |
| Investigational Site Number 642005 | Cluj-Napoca | 400015 | Romania |
| Investigational Site Number 642001 | Craiova | 200385 | Romania |
| Investigational Site Number 642002 | Timișoara | Romania |
| Investigational Site Number 643001 | Moscow | 115478 | Russia |
| Investigational Site Number 643005 | Saint Petersburg | 197758 | Russia |
| Investigational Site Number 643006 | Tula | 300053 | Russia |
| Investigational Site Number 643003 | Yaroslavl | 150054 | Russia |
| Investigational Site Number 410001 | Seoul | 120-752 | South Korea |
| Investigational Site Number 410003 | Seoul | 135-710 | South Korea |
| Investigational Site Number 410002 | Seoul | 138-736 | South Korea |
| Investigational Site Number 724002 | Badalona | 08916 | Spain |
| Investigational Site Number 724004 | Barcelona | 08035 | Spain |
| Investigational Site Number 724005 | Málaga | 29010 | Spain |
| Investigational Site Number 724001 | Valencia | 46026 | Spain |
| Investigational Site Number 804002 | Dnipropetrovsk | 49102 | Ukraine |
| Investigational Site Number 804004 | Donetsk | 83092 | Ukraine |
| Investigational Site Number 804001 | Lviv | 70031 | Ukraine |
| Evans TL, Cho BC, Udud K, Fischer JR, Shepherd FA, Martinez P, Ramlau R, Syrigos KN, Shen L, Chadjaa M, Wolf M. Cabazitaxel Versus Topotecan in Patients with Small-Cell Lung Cancer with Progressive Disease During or After First-Line Platinum-Based Chemotherapy. J Thorac Oncol. 2015 Aug;10(8):1221-8. doi: 10.1097/JTO.0000000000000588. |
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized population included all randomized participants, and was analyzed according to the randomized treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cabazitaxel | Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. |
| BG001 | Topotecan | Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG criteria:
| Number | participants |
| |||||||||||||||
| Primary Tumor Site | Number | participants |
| ||||||||||||||||
| Stage at Diagnosis | Disease stages were decided based on tumor size, lymph nodes and metastasis (as per National Comprehensive Cancer Network guidelines Version 2.2013). | Number | participants |
| |||||||||||||||
| Number of Organs Involved | Mean | Standard Deviation | organs |
|
| 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) | PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression. | Intent-to-treat (ITT) population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve. | ITT population. | Posted | Median | 95% Confidence Interval | months | From randomization to date of death (maximum 15 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Rate at Week 12 | Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Objective Tumor Response Rate | Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to disease progression/occurrence (maximum 7.6 months) |
|
|
All Adverse Events (AE) were collected from signature of the informed consent form until 30 days after last study treatment administration (maximum 66 weeks) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration until 30 days after the last dose of study treatment). Safety population all randomized participants who received at least one dose of study medication (treated).
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 | Cabazitaxel | Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. | 36 | 89 | 67 | 89 | ||
| EG001 | Topotecan | Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent. | 41 | 88 | 75 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary microemboli | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552428 | cabazitaxel |
| C532412 | XRP6258 |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Race: Black |
|
| Race: Asian/Oriental |
|
| Race: Other |
|
| Ethnicity: Hispanic |
|
| Ethnicity: Not Hispanic |
|
| 1 |
|
| 2 |
|
| Right Lung |
|
| Left Lung |
|
| Other: Mediastino-Hilar |
|
| IIB |
|
| IIIA |
|
| IIIB |
|
| IV |
|
| Unknown |
|
|
| Participants |
|
|
|
|