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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001962-13 | EudraCT Number |
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| Name | Class |
|---|---|
| NantCell, Inc. | INDUSTRY |
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This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study were to be guided by a Bayesian Logistic Regression Model (BLRM).
Once MTD/RP2D had been determined, patients were to be enrolled in two Phase II arms. Patients with PIK3CA mutated or amplified hormone receptor positive breast carcinoma were to be enrolled in Arm 1; patients with PIK3CA mutated or amplified ovarian carcinoma were to be enrolled in Arm 2. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BYL719 + AMG 479 | Experimental | For: Dose escalation phase/Phase II Expansion Phase. Cohorts of 3-6 patients were to be enrolled sequentially until an MTD or a recommended Phase II dose were defined. All patients were to receive the combination treatment. Sequential cohorts may receive different doses of the combination. In the Phase II expansion, all patients were to receive the same combination treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BYL719 | Drug | BYL719 is a small molecule inhibiting PI3-Kinase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities (DLTs) - Phase Ib | Phase lb only | 28 days |
| Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer. Overall response rate is defined as the proportion of patients who have a best overall response of complete response or partial response assessed per RECIST 1.1. | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib | The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1 | Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) |
| Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90095 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Patients with selected advanced solid tumors who had relapsed or progressed on standard therapy were treated in BYL719X2105J study with a combination of alpelisib and ganitumab. Phase I of the trial was by dose combination of the treatment. Phase II was by patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | BYL 200mg + AMG 12mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors |
| FG001 | BYL 300mg + AMG 12mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AMG 479 | Drug | AMG 479 is a monoclonal antibody directed against IGF1-R. |
|
|
The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1 |
| Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) |
| Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | the antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer. Phase II only, Cycle 1 Day 1 through Cycle 6 Day 28; assessed at baseline and every 8 weeks thereafter | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) |
| Cmax of BYL - Phase Ib | Serum concentration for BYL719 (alpelisib) 1 cycle - 28 days of treatment | Cycle 1 Day 1, Cycle 1 Day 15 |
| Area Under Curve (AUC) 0-24 Hour of BYL - Phase Ib | Area under curve for BYL719 (alpelisib) 1 cycle - 28 days of treatment | Cycle 1 Day 1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) |
| Tmax and T Half of BYL - Phase Ib | Tmax and half life of BYL719 (Alpelisib) 1 cycle - 28 days of treatment | Cycle 1 Day 1, Cycle 1 Day 15 |
| Cmax of AMG - Phase Ib | Serum concentration for AMG 479 (ganitumab) 1 cycle - 28 days of treatment | Cycle 1 Day 15 |
| Area Under Curve (AUC) 0-336 Hour of AMG - Phase Ib | Area under curve for AMG 479 (ganitumab) 1 cycle - 28 days of treatment | Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) |
| Tmax and T Half of AMG - Phase Ib | Tmax and half life of AMG 479 (ganitumab) 1 cycle - 28 days of treatment | Cycle 1 Day 15 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Novartis Investigative Site | New York | New York | 10017 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Toronto | Ontario | M5G 1Z6 | Canada |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28033 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| FG002 | BYL 350mg + AMG 12mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors |
| FG003 | HR+BC - Phase II | Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breast carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg. |
| FG004 | Ovarian - Phase II | Patients with PIK3CA mutated or amplified ovarian cancer were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg |
| FG005 | Non-HR+BC/Ovarian - Phase II | Patients with other than Breast and Ovarian cancer treated in the phase II part |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | BYL 200mg + AMG 12mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors |
| BG001 | BYL 300mg + AMG 12mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors |
| BG002 | BYL 350mg + AMG 12mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors |
| BG003 | HR+BC - Phase II | Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breast carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg. |
| BG004 | Ovarian - Phase II | Patients with PIK3CA mutated or amplified ovarian cancer were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg |
| BG005 | Non-HR+BC/Ovarian - Phase II | Patients with other than Breast and Ovarian cancer treated in the phase II part |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Full analysis set | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Full analysis set | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Dose Limiting Toxicities (DLTs) - Phase Ib | Phase lb only | Dose determining set (DDS): DDS includes all patients from the safety set who either met the minimum treatment exposure and safety evaluation requirements without experiencing DLT within Cycle 1 or experienced a DLT at any time during Cycle 1. | Posted | Number | Participants | 28 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer. Overall response rate is defined as the proportion of patients who have a best overall response of complete response or partial response assessed per RECIST 1.1. | Full analysis set (FAS). The full analysis set (FAS) includes all patients who received at least one full or partial dose of alpelisib or ganitumab. Patients were analyzed according to the planned treatment combination. | Posted | Number | 95% Confidence Interval | Percentages of participants | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib | The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1 | Full Analysis set | Posted | Number | Participants | Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib | The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1 | Full Analysis set | Posted | Number | 95% Confidence Interval | Percentages of participants | Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II | the antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer. Phase II only, Cycle 1 Day 1 through Cycle 6 Day 28; assessed at baseline and every 8 weeks thereafter | Full analysis set | Posted | Number | 95% Confidence Interval | Percentages of participants | Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of BYL - Phase Ib | Serum concentration for BYL719 (alpelisib) 1 cycle - 28 days of treatment | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1, Cycle 1 Day 15 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Area Under Curve (AUC) 0-24 Hour of BYL - Phase Ib | Area under curve for BYL719 (alpelisib) 1 cycle - 28 days of treatment | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1 Day 1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Tmax and T Half of BYL - Phase Ib | Tmax and half life of BYL719 (Alpelisib) 1 cycle - 28 days of treatment | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | Posted | Median | Full Range | hr | Cycle 1 Day 1, Cycle 1 Day 15 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Cmax of AMG - Phase Ib | Serum concentration for AMG 479 (ganitumab) 1 cycle - 28 days of treatment | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 15 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Area Under Curve (AUC) 0-336 Hour of AMG - Phase Ib | Area under curve for AMG 479 (ganitumab) 1 cycle - 28 days of treatment | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Tmax and T Half of AMG - Phase Ib | Tmax and half life of AMG 479 (ganitumab) 1 cycle - 28 days of treatment | Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received. | Posted | Median | Full Range | hr | Cycle 1 Day 15 |
|
|
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 4.5 years.
One patients with a tumor type other than Breast and Ovarian treated in the phase II part not represented.
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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 | BYL 200mg + AMG 12 mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors | 4 | 4 | 1 | 4 | 4 | 4 |
| EG001 | BYL 300mg + AMG 12 mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors | 8 | 10 | 5 | 10 | 10 | 10 |
| EG002 | BYL 350mg + AMG 12 mg/kg | BYL719 (alpelisib) and AMG 479 (ganitumab) regimen in patients with PIK3CA mutated or amplified solid tumors | 8 | 10 | 5 | 10 | 10 | 10 |
| EG003 | HR + BC - Phase II | Patients with PIK3CA mutated or amplified hormone receptor (HR) positive breat carcinoma (BC) were treated with alpelisib 300 mg once daily and ganitumab 12 mg/kg | 13 | 16 | 9 | 16 | 16 | 16 |
| EG004 | Ovarian - Phase II | Patients with other than Breast and Ovarian cancer treated in the phase II | 5 | 6 | 5 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Acute interstitial pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gingival erosion | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gingival recession | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
Due to the competitive landscape for anticancer therapies in ovarian and breast cancer and given the limited clinical activity observed with the study combination treatment, Novartis decided in 2014 to halt the recruitment in the trial.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1-888-669-6682 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C585539 | Alpelisib |
| C545764 | ganitumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native American |
|
| Title | Measurements |
|---|---|
|
| Rash maculopapular |
|
| Urticaria |
|
The total column "All patients" includes a patient with non-HR+BC and non-Ovarian cancer treated in the Phase II part. |
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| Units |
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| Counts |
|---|
| Participants |
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| Participants |
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