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Study terminated per recommendation of Data Review Team
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The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab + Gem/Cis | Experimental | Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle. |
|
| 50 mg QD AMG 706 + panitumumab + Gem/Cis | Experimental | AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle. |
|
| 75 mg QD AMG 706 + panitumumab + Gem/Cis | Experimental | AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle. |
|
| 100 mg QD AMG 706 + panitumumab + Gem/Cis | Experimental | AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 706 | Drug | AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Incidence of Adverse Events | The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting. | From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Objective Tumor Response | The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR. | From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks. |
Not provided
For complete inclusion and exclusion, please refer to the investigator.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21559248 | Background | Burris H, Stephenson J, Otterson GA, Stein M, McGreivy J, Sun YN, Ingram M, Ye Y, Schwartzberg LS. Safety and pharmacokinetics of motesanib in combination with panitumumab and gemcitabine-Cisplatin in patients with advanced cancer. J Oncol. 2011;2011:853931. doi: 10.1155/2011/853931. Epub 2011 Apr 14. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 2 December 2004 through 7 March 2007. This study was designed with two parts. However, Part 2 was not conducted due to safety issues found in Part 1. Thus Part 1 is referenced as the overall study here.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab + Gem/Cis | Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle. |
| FG001 | 50 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| FG002 | 75 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| FG003 | 100 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| FG004 | 125 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| FG005 | 75 mg BID AMG 706 + Panitumumab + Gem/Cis | AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab + Gem/Cis | Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle. |
| BG001 | 50 mg QD AMG 706 + Panitumumab + Gem/Cis |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With an Objective Tumor Response | The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR. | Efficacy Analysis Set, defined as defined as patients who received at least 1 dose of AMG 706 for AMG 706 treatment groups and patients who received at least 1 dose of panitumumab for the panitumumab-only treatment group. | Posted | Number | participants | From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks. |
|
From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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 | Panitumumab + Gem/Cis | Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| C000625785 | motesanib diphosphate |
| D000077544 | Panitumumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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| 125 mg QD AMG 706 + panitumumab + Gem/Cis | Experimental | AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle. |
|
| 75 mg BID AMG 706 + panitumumab + Gem/Cis | Experimental | AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle. |
|
| Panitumumab | Biological | Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle. |
|
|
| Gemcitabine | Drug | Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m^2. |
|
|
| Cisplatin | Drug | Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2. |
|
|
| Tmax | Time after dosing when maximum plasma concentration was observed for AMG 706 | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
| Cmax | The maximum observed plasma concentration after AMG 706 dosing | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
| AUC0-24 | Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method. | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
| AUC0-inf | Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort. | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
| Death |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
| BG002 | 75 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| BG003 | 100 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| BG004 | 125 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| BG005 | 75 mg BID AMG 706 + Panitumumab + Gem/Cis | AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG001 | 50 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| OG002 | 75 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| OG003 | 100 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| OG004 | 125 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
| OG005 | 75 mg BID AMG 706 + Panitumumab + Gem/Cis | AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. |
|
|
| Secondary | Tmax | Time after dosing when maximum plasma concentration was observed for AMG 706 | The Pharmacokinetic (PK) Analysis Set consists of patients who had dosing and PK sampling times recorded on the day of PK sample collection and no significant protocol deviations that impacted the quality of the PK data (for example, sample processing errors and/or inaccurate dosing on the day of the PK sampling). | Posted | Median | Full Range | hours | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
|
|
|
| Secondary | Cmax | The maximum observed plasma concentration after AMG 706 dosing | PK analysis set. | Posted | Mean | Standard Deviation | ng/mL | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
|
|
|
| Secondary | AUC0-24 | Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method. | PK Analysis set; Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations. | Posted | Mean | Standard Deviation | μg*hr/mL | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
|
|
|
| Secondary | AUC0-inf | Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort. | PK analysis set. Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations. | Posted | Mean | Standard Deviation | μg*hr/mL | Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. |
|
|
|
| Primary | Participant Incidence of Adverse Events | The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting. | Safety Analysis Set, composed of all participants in the AMG 706 treatment groups who received at least one dose of AMG 706 and all participants in the panitumumab-only treatment group who received at least one dose of panitumumab. | Posted | Number | Participants | From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. |
|
|
|
| 2 |
| 8 |
| 8 |
| 8 |
| EG001 | 50 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. | 4 | 8 | 8 | 8 |
| EG002 | 75 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. | 3 | 6 | 6 | 6 |
| EG003 | 100 mg QD AMG 706 + Panitumumab + Gem/Cis | AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. | 4 | 6 | 6 | 6 |
| EG004 | 125 mg QD AMG 706 + Panitumumab + Gem/CisEdit | AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. | 9 | 11 | 11 | 11 |
| EG005 | 75 mg BID AMG 706 + Panitumumab + Gem/CisEdit | AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle. | 1 | 2 | 2 | 2 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Narcotic intoxication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypocoagulable state | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Visual disturbance | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rectal discharge | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Application site rash | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Catheter site discharge | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Crepitations | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Extravasation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Adenoviral conjunctivitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infected sebaceous cyst | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nail bed infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Prothrombin time ratio increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Appetite disorder | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Central venous catheterisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |