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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003441-13 |
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The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentinâ„¢)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cediranib 45 mg Fed | Experimental | Part A: Cediranib 45 mg Fed State |
|
| Cediranib 45 mg Fasted | Experimental | Part A: Cediranib 45 mg Fasted State |
|
| Cediranib 45 mg Fixed Dose | Experimental | Part B: Cediranib 45 mg Fixed Dose |
|
| Cediranib 30 - 90 mg Dose Escalation | Experimental | Part B: Cediranib 30 - 90 mg Dose Escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cediranib | Drug | 45 mg oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area Under Plasma Concentration-time Curve (AUC) | Area under plasma concentration-time curve from zero to infinity | Measurements were collected up to 168 hours (following single dosing). |
| Part A: Maximum Plasma (Peak) Concentration (Cmax) | Maximum plasma drug concentration | Measurements were collected up to 168 hours (following single dosing). |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: AUC (0-t) | Area under the curve from time 0 to the last measureable time point | Measurements were collected up to 168 hours (following single dosing). |
| Part A: Time to Peak or Maximum Concentration (Tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AZD2171 Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glasgow | United Kingdom | ||||
| Research Site |
60 patients were enrolled though only 45 patients were randomized to Part A and 47 to Part B.
Completion of Part B means completed at least 16 weeks of treatment.
This was a two part study.Part A had two arms, fed/fasted and fasted/fed. Part B had two arms, a fixed dose arm and a dose escalation arm.Patients(pts)in Part A were allowed to go in to Part B. Pts who chose not to go in to Part B discontinued the study.Additionally new pts were recruited to Part B. In Parts A/B, there was a total of 60 pts.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cediranib 45 mg Fed | Part A: Cediranib 45 mg Fed State |
| FG001 | Cediranib 45 mg Fasted | Part A: Cediranib 45 mg Fasted State |
| FG002 | Cediranib 45 mg Fixed Dose | Part B: Cediranib 45 mg Fixed Dose |
| FG003 | Cediranib 30 to 90 mg Dose Escalation | Part B: Cediranib Dose Escalation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
|
| ||||||||||||||||||
| Part B |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cediranib 45 mg Fed | Part A: Cediranib 45 mg Fed State |
| BG001 | Cediranib 45 mg Fasted | Part A: Cediranib 45 mg Fasted State |
| 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 | Part A: Area Under Plasma Concentration-time Curve (AUC) | Area under plasma concentration-time curve from zero to infinity | Posted | Apr 2012 | Geometric Mean | Full Range | ng*h/mL | Measurements were collected up to 168 hours (following single dosing). |
|
|
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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 | Cediranib 45 mg Part A | Part A: Cediranib 45 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C500926 | cediranib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| Cediranib 30 - 90 mg | Drug | oral tablet dose escalation |
|
|
Time to reach peak or maximum concentration or maximum response
| Measurements were collected up to 168 hours (following single dosing). |
| Part A: Terminal Phase Half-life (t1/2λz) | Terminal phase half-life | Measurements were collected up to 168 hours (following single dosing). |
| Part A: Apparent Total Body Clearance (CL/F) | Apparent total body clearance of drug from plasma | Measurements were collected up to 168 hours (following single dosing). |
| Part B: Best Overall Response Rate (ORR) | Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).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).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions. Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions | Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation. |
| Part B: Progression-free Survival (PFS) | Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing non-target lesions. | Number of days 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. |
| Headington |
| United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Condition under investigation worsened |
|
| Incorrect enrol/entry crit not fulfilled |
|
| Partial bowel obstruction |
|
| Reaccumul. of ascites following drainage |
|
| Suspicion of second malignancy |
|
| QTC interval outwith elig. criteria |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Cediranib 45 mg Fixed Dose | Part B: Cediranib 45 mg Fixed Dose |
| BG003 | Cediranib 30 to 90 mg Dose Escalation | Part B: Cediranib Dose Escalation |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Number | participants |
|
| Participants |
|
|
| Primary | Part A: Maximum Plasma (Peak) Concentration (Cmax) | Maximum plasma drug concentration | Posted | Apr 2012 | Geometric Mean | Full Range | ng/mL | Measurements were collected up to 168 hours (following single dosing). |
|
|
|
| Secondary | Part A: AUC (0-t) | Area under the curve from time 0 to the last measureable time point | Posted | Apr 2012 | Geometric Mean | Full Range | ng*h/mL | Measurements were collected up to 168 hours (following single dosing). |
|
|
|
| Secondary | Part A: Time to Peak or Maximum Concentration (Tmax) | Time to reach peak or maximum concentration or maximum response | Posted | Apr 2012 | Geometric Mean | Full Range | hr | Measurements were collected up to 168 hours (following single dosing). |
|
|
|
| Secondary | Part A: Terminal Phase Half-life (t1/2λz) | Terminal phase half-life | Posted | Apr 2012 | Geometric Mean | Full Range | hr | Measurements were collected up to 168 hours (following single dosing). |
|
|
|
| Secondary | Part A: Apparent Total Body Clearance (CL/F) | Apparent total body clearance of drug from plasma | Posted | Apr 2012 | Geometric Mean | Full Range | L/h | Measurements were collected up to 168 hours (following single dosing). |
|
|
|
| Secondary | Part B: Best Overall Response Rate (ORR) | Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).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).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions. Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions | ITT (intention-to-treat ) patients with baseline RECIST data | Posted | Apr 2012 | Number | Participants | Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation. |
|
|
|
| Secondary | Part B: Progression-free Survival (PFS) | Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing non-target lesions. | ITT (intention-to-treat ) patients with baseline RECIST data.One patient was randomized and had baseline RECIST assessments, but did not have any further RECIST assessments. Therefore they were censored at baseline, meaning the lowest value in the range was set to zero. | Posted | Apr 2012 | Median | Full Range | Days | Number of days 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. |
|
|
|
| 6 |
| 39 |
| 34 |
| 39 |
| EG001 | Cediranib 45 mg Fixed Dose | Part B: Cediranib 45 mg Fixed Dose | 9 | 16 | 16 | 16 |
| EG002 | Cediranib 30 - 90 mg Dose Escalation | Cediranib 30 - 90 mg Dose Escalation | 20 | 31 | 31 | 31 |
| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastric Perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bile Duct Obstruction | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Central Line Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Clostridial Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Viral Labyrinthitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tracheostomy Malfunction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intracranial Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Spinal Cord Compression | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal Disorder | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobinaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bundle Branch Block Right | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deafness Unilateral | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Visual Disturbance | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epigastric Discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lip Blister | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tongue Ulceration | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Unevaluable Event | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenic Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mobility Decreased | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Disorder | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urine Odour Abnormal | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin Induration | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 10.0 | 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.