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The purpose of this study is to find out what effects (good and bad) AZD1775 used in combination with carboplatin and paclitaxel will have on participants and their cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin/Paclitaxel/AZD1775 | Experimental | Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is measured from date of first study treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the duration of time from the date for first treatment (Cycle 1 Day 1) to the date of death. | Up to 2 years |
| Duration of Overall Response (OR) | The duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jhanelle Gray, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States | ||
| Ohio State University Comprehensive Cancer Center |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboplatin/Paclitaxel/AZD1775 | Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment. Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. Paclitaxel: Participants will be treated with paclitaxel 175 mg/m^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboplatin/Paclitaxel/AZD1775 | Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment. Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. Paclitaxel: Participants will be treated with paclitaxel 175 mg/m^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. |
| 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 | Progression Free Survival (PFS) | PFS is measured from date of first study treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Evaluable participants | Posted | Median | 80% Confidence Interval | months | Up to 2 years |
|
Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
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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 | Carboplatin/Paclitaxel/AZD1775 | Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment. Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. Paclitaxel: Participants will be treated with paclitaxel 175 mg/m^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jhanelle E. Gray, MD | Moffitt Cancer Center | 813-745-2677 | Jhanelle.Gray@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2020 | Nov 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C549567 | adavosertib |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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|
| Paclitaxel | Drug | Participants will be treated with paclitaxel 175 mg/m^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. |
|
|
| AZD1775 | Drug | Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment. |
|
|
| Up to 2 years |
| Percentage of Participants With Disease Control | DCR: Complete Response (CR), Partial Response (PR), and Stable Disease (SD). | Up to 2 years |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Survival (OS) | OS is defined as the duration of time from the date for first treatment (Cycle 1 Day 1) to the date of death. | Evaluable participants | Posted | Median | 80% Confidence Interval | months | Up to 2 years |
|
|
|
| Secondary | Duration of Overall Response (OR) | The duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | Evaluable participants | Posted | Median | 80% Confidence Interval | months | Up to 2 years |
|
|
|
| Secondary | Percentage of Participants With Disease Control | DCR: Complete Response (CR), Partial Response (PR), and Stable Disease (SD). | Evaluable participants | Posted | Number | 80% Confidence Interval | percentage | Up to 2 years |
|
|
|
| 4 |
| 42 |
| 26 |
| 42 |
| 40 |
| 42 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| General disorders and administration site conditions -Other | General disorders | CTCAE (4.0) | Non-systematic Assessment | Pain from left gluteal mass |
|
| Generalized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infections and Infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Salmonella |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pancytopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleural infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Chest pain - Cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders -Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pericardial tamponade | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain in extremity | General disorders | CTCAE (4.0) | Non-systematic Assessment | bilateral lower extremity pain due to venous thrombosis |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rectal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema face | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Aphonia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Muscle weakness trunk | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleural infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cardiac disorders - Other | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pericardial tamponade | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |