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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT no. 2006-002455-33 |
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Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Cediranib placebo |
|
| 2 | Experimental | Cediranib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cediranib | Drug | 45 mg oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Tumour Size at 12 Weeks | Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100 | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Best Percentage Change From Baseline in Tumour Size During the Study | Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions | Treatment period up to Week 12 visit date for last patient in (LPI) |
| Duration of Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Groningen | Netherlands | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22285180 | Derived | Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L, Jurgensmeier JM, Gore ME. Cediranib monotherapy in patients with advanced renal cell carcinoma: results of a randomised phase II study. Eur J Cancer. 2012 Mar;48(4):527-37. doi: 10.1016/j.ejca.2011.12.022. Epub 2012 Jan 28. |
| Label | URL |
|---|---|
| CSR-D8480C00030.pdf | View source |
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Seventy-one patients were randomised to study treatment: 53 to cediranib 45 mg and 18 to placebo. Following unblinding for the primary analysis, all patients, except those who had progressed on cediranib, then had the option of receiving open-label treatment with cediranib. Randomised=ITT=Safety set: Cediranib 45mg 53, Placebo 18.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD2171 45 mg | AZD2171 45mg/Day: 53 patients randomised |
| FG001 | Placebo | Placebo / Day: 18 patients randomised |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD2171 45 mg | AZD2171 45mg/Day |
| BG001 | Placebo | Placebo/Day |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at informed consent |
| 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 | Percentage Change From Baseline in Tumour Size at 12 Weeks | Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100 | For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline to Week 12 |
|
Not provided
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 | Cediranib DB | Double Blind part |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splinter Haemorrhages | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C500926 | cediranib |
Not provided
Not provided
Not provided
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| Cediranib Placebo | Drug | oral tablet |
|
Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies. |
| Treatment period up to 2nd data cut-off of 8th March 2009 |
| Progression Free Survival | Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. | Treatment period up to 2nd data cut-off of 8th March 2009. |
| Objective Tumour Response at 12 Weeks | Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression. | Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12. |
| Best Objective Tumour Response | Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE). | Baseline, Week 12 and every 8 weeks thereafter or until progression. |
| Leiden |
| Netherlands |
| Research Site | Nijmegen | Netherlands |
| Research Site | Birmingham | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Northwood | United Kingdom |
| Research Site | Oxford | United Kingdom |
| Condition under investigation worsened |
|
| Progressive at Week 6 |
|
| Unblinded before 12 weeks |
|
| Total |
Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Gender | Gender at informed consent | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Best Percentage Change From Baseline in Tumour Size During the Study | Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions | For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data. | Posted | Mean | Standard Deviation | Percentage change from baseline | Treatment period up to Week 12 visit date for last patient in (LPI) |
|
|
|
| Secondary | Duration of Response | Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies. | For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)). 13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off. | Posted | Median | Inter-Quartile Range | Months | Treatment period up to 2nd data cut-off of 8th March 2009 |
|
|
|
| Secondary | Progression Free Survival | Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. | Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised to placebo. All patients irrespective of whether they had a 12 week scan are included in this analysis. At week 12 placebo patients were able to switch to cediranib. | Posted | Median | Full Range | Months | Treatment period up to 2nd data cut-off of 8th March 2009. |
|
|
|
| Secondary | Objective Tumour Response at 12 Weeks | Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression. | Posted | Number | Participants | Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12. |
|
|
|
| Secondary | Best Objective Tumour Response | Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE). | For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a 'best response' summary. | Posted | Number | Participants | Baseline, Week 12 and every 8 weeks thereafter or until progression. |
|
|
|
| 10 |
| 53 |
| 53 |
| 53 |
| EG001 | Placebo DB | Double Blind part | 3 | 18 | 16 | 18 |
| EG002 | Cediranib OL | Open Label part | 15 | 58 | 57 | 58 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Blood Calcium Increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intracranial Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Loss Of Consciousness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Reversible Posterior Leukoencephalopathy Syndrome | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bartholin's Cyst | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermatitis Bullous | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Feeling Cold | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Appetite Disorder | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cold Sweat | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |