Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CVX-060-101 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVX-060 | Biological | Weekly, intravenous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline (Day 0) up to 30 days after last dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) | |
| Serum Decay Half-Life (t1/2) | Serum decay half-life is the time measured for the serum concentration to decrease by one half. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Medical Imaging, Ltd. | Scottsdale | Arizona | 85255 | United States | ||
| Premiere Oncology of Arizona |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | CVX-060 0.3 mg/kg (Stage 1) | CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| FG001 | CVX-060 1 mg/kg (Stage 1) | CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| FG002 | CVX-060 3 mg/kg (Stage 1) | CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| FG003 | CVX-060 6 mg/kg (Stage 1) | CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| FG004 | CVX-060 12 mg/kg (Stage 1) | CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| FG005 | CVX-060 15 mg/kg (Stage 1) | CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| FG006 | CVX-060 15 mg/kg (Stage 2) | CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1: Dose Escalation |
|
| ||||||||||||||||||
| Stage 2: Expanded Cohort |
|
Safety population included all enrolled participants in the study who received any study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CVX-060 (Stage 1 and 2) | CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2, administered once-weekly in a 4-week cycle. |
| 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 | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Safety population included all enrolled participants in the study who received any study medication. | Posted | Number | participants | Baseline (Day 0) up to 30 days after last dose of study medication |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CVX-060 0.3 mg/kg (Stage 1) | CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
Designation of outcomes as primary, secondary was based on study team's input as study did not specify them as primary or secondary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
| Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7). | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
| Apparent Volume of Distribution (Vss) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed. | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
| Apparent Clearance (CL) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
| Recommended Phase 2 Dose (RP2D): Stage 1 | RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3. | Baseline (Day 0) up to 42 days after the last dose of study medication |
| Number of Participants With Anti-CVX-060 Antibodies | Baseline (Day 0) up to 42 days after last dose |
| Number of Samples From Participants With Anti-CVX-060 Antibodies | Baseline (Day 0) up to 42 days after last dose |
| Number of Participants With Best Overall Response (BOR) | BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported. | Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133) |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Premiere Oncology, A Medical Corporation | Santa Monica | California | 90404 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Progressive Disease |
|
| Investigator declined participation |
|
| Death |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| CVX-060 0.3 mg/kg (Stage 1) |
CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| OG001 | CVX-060 1 mg/kg (Stage 1) | CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| OG002 | CVX-060 3 mg/kg (Stage 1) | CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| OG003 | CVX-060 6 mg/kg (Stage 1) | CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| OG004 | CVX-060 12 mg/kg (Stage 1) | CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| OG005 | CVX-060 15 mg/kg (Stage 1) | CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). |
| OG006 | CVX-060 15 mg/kg (Stage 2) | CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage. |
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) | Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
|
|
|
| Secondary | Serum Decay Half-Life (t1/2) | Serum decay half-life is the time measured for the serum concentration to decrease by one half. | PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Mean | Standard Deviation | hours | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
|
|
|
| Secondary | Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7). | PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Geometric Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
|
|
|
| Secondary | Apparent Volume of Distribution (Vss) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed. | PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Geometric Mean | Standard Deviation | milliliter per kilogram (mL/kg) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
|
|
|
| Secondary | Apparent Clearance (CL) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. | PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Geometric Mean | Standard Deviation | (mL/hr)/kg | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
|
|
|
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) | PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Median | Full Range | hours | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) |
|
|
|
| Secondary | Recommended Phase 2 Dose (RP2D): Stage 1 | RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3. | Safety population included all enrolled participants in the study who received any study medication. | Posted | Number | (mg/kg)/week | Baseline (Day 0) up to 42 days after the last dose of study medication |
|
|
|
| Secondary | Number of Participants With Anti-CVX-060 Antibodies | Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Number | participants | Baseline (Day 0) up to 42 days after last dose |
|
|
|
| Secondary | Number of Samples From Participants With Anti-CVX-060 Antibodies | Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data. | Posted | Number | samples | Baseline (Day 0) up to 42 days after last dose | Samples | Participants |
|
|
|
| Secondary | Number of Participants With Best Overall Response (BOR) | BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported. | Safety population included all enrolled participants in the study who received any study medication. | Posted | Number | participants | Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133) |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | CVX-060 1 mg/kg (Stage 1) | CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). | 0 | 3 | 3 | 3 |
| EG002 | CVX-060 3 mg/kg (Stage 1) | CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). | 2 | 3 | 3 | 3 |
| EG003 | CVX-060 6 mg/kg (Stage 1) | CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). | 3 | 6 | 6 | 6 |
| EG004 | CVX-060 12 mg/kg (Stage 1) | CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). | 0 | 3 | 3 | 3 |
| EG005 | CVX-060 15 mg/kg (Stage 1) | CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1). | 0 | 3 | 3 | 3 |
| EG006 | CVX-060 15 mg/kg (Stage 2) | CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage. | 3 | 13 | 12 | 13 |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Ocular retrobulbar haemorrhage | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Early satiety | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Smear cervix abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Vulvovaginal swelling | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Suture removal | Surgical and medical procedures | MedDRA 17.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|