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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005294-60 | EudraCT Number |
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The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Progressive or metastatic bone or soft tissue sarcomas |
|
| Arm 2 | Experimental | Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line |
|
| Arm 3 | Experimental | Progressive or metastatic alveolar soft part sarcoma (ASPS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | 2.5 and 5 mg tablets taken orally and starting dose was 10 mg daily for all patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rates by Week 16 (ITT) | The best overall response is the best response recorded from treatment start until disease progression/recurrence (both measurement and confirmation criteria). Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions): Complete Response (CR)=at least two determinations of CR 4 weeks apart before progression, Partial Response (PR)=at least two determinations of CR 4 weeks apart before progression (and not qualifying for a CR), Stable Disease (SD)=at least one SD assessment >6 weeks after start of treatment and Progressive Disease (PD)=Progression or death due to underlying cancer ≤16 weeks after start of treatment. PD without radiologic evidence were classified as progression only, when clear evidence of clinical deterioration was available and patient discontinued due to "disease progression". Unknown (UNK) = all other cases. | Baseline up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response Rates (Complete Response and Partial Response) at Week 16 (ITT) | The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions). |
Not provided
Inclusion Criteria:
Histological evidence of progressive or metastatic bone or soft tissue sarcoma.
The following tumor types are included:
malignant fibrous histiocytoma
liposarcoma
synovial sarcoma
malignant paraganglioma
fibrosarcoma
leiomyosarcoma
angiosarcoma including haemangiopericytoma
malignant peripheral nerve sheath tumor
STS, not otherwise specified
miscellaneous sarcoma including mixed mesodermal tumors of the uterus
osteosarcoma
Ewing's sarcoma
rhabdomyosarcoma
gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
alveolar soft part sarcoma (ASPS)
a 20% increase in the sum of unidimensionally measured target lesions
a new lesion
unequivocal increase in non-measurable disease.
Exclusion Criteria:
Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.
The following tumor types will not be included:
Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
Neurotoxicity > grade 2 CTC.
Radiation of the lung.
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bad Saarow | 15526 | Germany | |||
| Novartis Investigative Site |
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Seventy-four patients were screened and seventy-one enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Progressive or metastatic bone or soft tissue sarcomas |
| FG001 | Arm 2 | Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line |
| FG002 | Arm 3 | Progressive or metastatic alveolar soft part sarcoma (ASPS) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Progressive or metastatic bone or soft tissue sarcomas |
| BG001 | Arm 2 | Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Best Overall Response Rates by Week 16 (ITT) | The best overall response is the best response recorded from treatment start until disease progression/recurrence (both measurement and confirmation criteria). Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions): Complete Response (CR)=at least two determinations of CR 4 weeks apart before progression, Partial Response (PR)=at least two determinations of CR 4 weeks apart before progression (and not qualifying for a CR), Stable Disease (SD)=at least one SD assessment >6 weeks after start of treatment and Progressive Disease (PD)=Progression or death due to underlying cancer ≤16 weeks after start of treatment. PD without radiologic evidence were classified as progression only, when clear evidence of clinical deterioration was available and patient discontinued due to "disease progression". Unknown (UNK) = all other cases. | Posted | Number | percentage of participants | Baseline up to 16 weeks |
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 16 weeks
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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 | Arm I | Progressive or metastatic bone or soft tissue sarcomas | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2013 | May 14, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 7, 2011 | May 14, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Baseline up to approximately 16 weeks |
| Percentage of Participants With Duration of Response (CR, PR, SD) at 16 Weeks. | Duration of response (CR, PR or SD) applied only to those patients whose best overall response was CR, PR or SD based on local radiologic assessments and was defined as the time from start of treatment to progression or death from underlying disease. Patients not experiencing progression or death at 16 weeks were censored with the date of their last tumor assessment. Duration of response was explored using the Kaplan-Meier method. | Baseline up to 16 weeks |
| Percentage of Participants With Progression-free Survival (PFS) at 16 Weeks | Progression-free Survival (PFS) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from any cause. If a patient had not had an event, PFS was censored at the date of the last adequate tumor assessment at week 16 | 16 weeks |
| Time to Progression (TTP) (ITT) | Time to progression (TTP) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from underlying disease. If a patient had not had an event, TTP was censored at the date of the last adequate tumor assessment, which was the date of Visit 6 (Week 16) for the core phase and the last available tumor assessment for the follow-up phase. TTP was explored by using the Kaplan-Meier method. | Baseline up to 16 weeks |
| Percentage of Participants With Overall Survival (OS) at Week 16 (ITT) | Overall survival (OS) was defined as the time from the date of start of treatment to death from any cause. If a patient was not known to have died (was alive), OS was censored at the date of the last contact, which was the date of Visit 6 (Week 16) for the core phase and the last available visit for the follow-up phase. OS was explored by using the Kaplan-Meier method. One death occurred in Arm 3 after Week 16. | Baseline up to 16 weeks |
| Düsseldorf |
| 40479 |
| Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Mannheim | 68167 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Administrative problems |
|
| Death |
|
| Adverse Event |
|
| Abnormal lab values |
|
| Lost to Follow-up |
|
| BG002 | Arm 3 | Progressive or metastatic alveolar soft part sarcoma (ASPS) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Progressive or metastatic bone or soft tissue sarcomas |
| OG001 | Arm 2 | Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line |
| OG002 | Arm 3 | Progressive or metastatic alveolar soft part sarcoma (ASPS) |
|
|
|
| Secondary | Objective Tumor Response Rates (Complete Response and Partial Response) at Week 16 (ITT) | The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions). | Posted | Number | percentage of participants | Baseline up to approximately 16 weeks |
|
|
|
| Secondary | Percentage of Participants With Duration of Response (CR, PR, SD) at 16 Weeks. | Duration of response (CR, PR or SD) applied only to those patients whose best overall response was CR, PR or SD based on local radiologic assessments and was defined as the time from start of treatment to progression or death from underlying disease. Patients not experiencing progression or death at 16 weeks were censored with the date of their last tumor assessment. Duration of response was explored using the Kaplan-Meier method. | Posted | Number | percentage of participants | Baseline up to 16 weeks |
|
|
|
| Secondary | Percentage of Participants With Progression-free Survival (PFS) at 16 Weeks | Progression-free Survival (PFS) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from any cause. If a patient had not had an event, PFS was censored at the date of the last adequate tumor assessment at week 16 | Posted | Number | percentage of participants | 16 weeks |
|
|
|
| Secondary | Time to Progression (TTP) (ITT) | Time to progression (TTP) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from underlying disease. If a patient had not had an event, TTP was censored at the date of the last adequate tumor assessment, which was the date of Visit 6 (Week 16) for the core phase and the last available tumor assessment for the follow-up phase. TTP was explored by using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | days | Baseline up to 16 weeks |
|
|
|
| Secondary | Percentage of Participants With Overall Survival (OS) at Week 16 (ITT) | Overall survival (OS) was defined as the time from the date of start of treatment to death from any cause. If a patient was not known to have died (was alive), OS was censored at the date of the last contact, which was the date of Visit 6 (Week 16) for the core phase and the last available visit for the follow-up phase. OS was explored by using the Kaplan-Meier method. One death occurred in Arm 3 after Week 16. | Posted | Number | percentage of participants | Baseline up to 16 weeks |
|
|
|
| 37 |
| 15 |
| 37 |
| 35 |
| 37 |
| EG001 | Arm II | Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line | 4 | 24 | 14 | 24 | 21 | 24 |
| EG002 | Arm III | Progressive or metastatic alveolar soft part sarcoma (ASPS) | 1 | 10 | 8 | 10 | 10 | 10 |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| SUBILEUS | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| LOCALISED OEDEMA | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| PAIN | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| PERITONITIS BACTERIAL | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| SUPERINFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| BONE CONTUSION | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| JAW FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| ALVEOLAR SOFT PART SARCOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| COGNITIVE DISORDER | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| DISORIENTATION | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| FEAR | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| CAPILLARY LEAK SYNDROME | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| ANAEMIA OF MALIGNANT DISEASE | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| BUNDLE BRANCH BLOCK RIGHT | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| CARDIOMEGALY | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
|
| CUSHING'S SYNDROME | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
|
| HYPERTHYROIDISM | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
|
| TOXIC NODULAR GOITRE | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| MYOPIA | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| PROCTITIS | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| DYSPLASIA | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| GENERALISED OEDEMA | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| IMPAIRED HEALING | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| MEDICAL DEVICE PAIN | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| PAIN | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| PERIPHERAL SWELLING | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| HEPATIC LESION | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
|
| CONTRAST MEDIA ALLERGY | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| CHRONIC SINUSITIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| FEBRILE INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| ORAL INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| CLOSTRIDIUM TEST POSITIVE | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| CACHEXIA | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| TYPE 1 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| MUSCULOSKELETAL DISORDER | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| DYSAESTHESIA | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| NOCTURIA | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| AMENORRHOEA | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| VAGINAL DISCHARGE | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| VULVOVAGINAL INFLAMMATION | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DRY THROAT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| TELANGIECTASIA | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| AORTIC ANEURYSM | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| LYMPHOEDEMA | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
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