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This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with erlotinib plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib plus Gemcitabine | Patients with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib | Drug | Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Stratified by Rash | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Rash by Severity | Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic pancreatic cancer
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der Universität zu Köln Klinik für Gastroenterologie am Abdominalzentrum | Cologne | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32093649 | Derived | Westphalen CB, Kukiolka T, Garlipp B, Hahn L, Fuchs M, Malfertheiner P, Reiser M, Kutting F, Heinemann V, Beringer A, Waldschmidt DT. Correlation of skin rash and overall survival in patients with pancreatic cancer treated with gemcitabine and erlotinib - results from a non-interventional multi-center study. BMC Cancer. 2020 Feb 24;20(1):155. doi: 10.1186/s12885-020-6636-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib Plus Gemcitabine | Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population included all subjects who received at least one treatment with study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib Plus Gemcitabine | Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment. |
| 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 | Overall Survival Stratified by Rash | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no. | Full Analysis Set (FAS) included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | Posted | Median | 95% Confidence Interval | months | Up to 12 months |
|
Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
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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 | Erlotinib Plus Gemcitabine | Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| gemcitabine | Drug | Study participants will receive gemcitabine according to Summary of Product Characteristics (SmPC) |
|
| Up to 12 months |
| Number of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to 12 months |
| Number of Dose Modifications and Dose Withdrawals of Erlotinib | Reported is the total number of dose modifications/withdrawals for erlotinib. | Up to 12 months |
| Number of Dose Modifications and Dose Withdrawals of Gemcitabine | Reported is the number of dose modifications/withdrawals for gemcitabine. | Up to 12 months |
| Time of Onset of Rash After Start Erlotinib Treatment | Reported is the number of days from first erlotinib treatment to first rash onset. | Up to 12 months |
| Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. | Up to 12 months |
| Percentage of Participants With Best Overall Response | Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice. | Up to 12 months |
| Time to Disease Progression | Disease progression was defined in accordance with daily routine practice. | Up to 12 months |
| Score in Patient Questionnaire: Possible Side Effects | Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 |
| Score in Participant Questionnaire: What to Do in Case of Side Effect | Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 |
| Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 |
| Score in Participant Questionnaire: Quality of Life | Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study. | At Weeks 4, 8, 9 and 16 |
| Lost to Follow-up |
|
| Withdrawal of informed consent |
|
| Absent rash |
|
| Physician Decision |
|
| Patient's wish |
|
| Tumor progression |
|
| Death |
|
| Study completion unknown |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Rash by Severity | Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. | Safety population included all participants who received at least one treatment with study medication. | Posted | Number | participants | Up to 12 months |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Safety population included all participants who received at least one treatment with study medication. | Posted | Number | participants | Up to 12 months |
|
|
|
| Secondary | Number of Dose Modifications and Dose Withdrawals of Erlotinib | Reported is the total number of dose modifications/withdrawals for erlotinib. | Safety population included all participants who received at least one treatment with study medication | Posted | Number | dose modifications/withdrawals | Up to 12 months |
|
|
|
| Secondary | Number of Dose Modifications and Dose Withdrawals of Gemcitabine | Reported is the number of dose modifications/withdrawals for gemcitabine. | Safety population included all participants who received at least one treatment with study medication | Posted | Number | dose modifications/withdrawals | Up to 12 months |
|
|
|
| Secondary | Time of Onset of Rash After Start Erlotinib Treatment | Reported is the number of days from first erlotinib treatment to first rash onset. | Safety population included all participants who received at least one treatment with study medication. | Posted | Mean | Standard Deviation | days | Up to 12 months |
|
|
|
| Secondary | Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. | FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | Posted | Median | 95% Confidence Interval | months | Up to 12 months |
|
|
|
| Secondary | Percentage of Participants With Best Overall Response | Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice. | FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | Posted | Number | percentage of participants | Up to 12 months |
|
|
|
| Secondary | Time to Disease Progression | Disease progression was defined in accordance with daily routine practice. | FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine. | Posted | Median | 95% Confidence Interval | months | Up to 12 months |
|
|
|
| Secondary | Score in Patient Questionnaire: Possible Side Effects | Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. | Safety population included all participants who received at least one treatment with study medication. | Posted | Mean | Standard Deviation | scores on a scale | At Weeks 4, 8, 9 and 16 |
|
|
|
| Secondary | Score in Participant Questionnaire: What to Do in Case of Side Effect | Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. | Safety population included all participants who received at least one treatment with study medication. | Posted | Mean | Standard Deviation | scores on a scale | At Weeks 4, 8, 9 and 16 |
|
|
|
| Secondary | Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study. | Safety population included all participants who received at least one treatment with study medication. | Posted | Mean | Standard Deviation | scores on a scale | At Weeks 4, 8, 9 and 16 |
|
|
|
| Secondary | Score in Participant Questionnaire: Quality of Life | Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study. | Safety population included all participants who received at least one treatment with study medication. | Posted | Mean | Standard Deviation | scores on a scale | At Weeks 4, 8, 9 and 16 |
|
|
|
| 171 |
| 338 |
| 261 |
| 338 |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric stenosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Adverse event | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stent malfunction | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ulcer | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ulcer haemorrhage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholestatis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hydrocholecystis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Jaundice extrahepatic obstructive | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cholangitis infective | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Biliary anastomosis complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood alkaline phosphatase abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood bilirubin abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Haemoglobin abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diet refusal | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Tumour invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| IIIrd nerve disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Personality change | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bile duct stent insertion | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Trousseau's syndrome | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Haemoglobin abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Platelet count abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Paronychia Grade 3 |
|
| Dry skin Grade 1 |
|
| Dry skin Grade 2 |
|
| Papulopustulous eczema Grade 1 |
|
| Papulopustulous eczema Grade 2 |
|
| Papulopustulous eczema Grade 3 |
|
|
| Week 9 |
|
|
| Week 16 |
|
|
|
| Week 9 |
|
|
| Week 16 |
|
|
|
| Week 9 |
|
|
| Week 16 |
|
|
|
| Week 9 |
|
|
| Week 16 |
|
|