Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
| United BioSource, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy. The study is also looking at the safety of S-1.
Locally advanced or metastatic pancreatic cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1 30 mg/m^2 | Experimental | Participants received 30 milligrams per meter square (mg/m^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Tumor Response Rate (ORR) | ORR was defined as the percentage of participants with objective evidence of partial response (PR) or complete response (CR) and was based on the best overall response across all cycles for each participant. Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST). For target lesions response, CR was defined as the disappearance of all target lesions for at least 3 weeks and PR was defined as at least a 30% reduction in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum of the longest diameters for at least 6 weeks. For non-target lesions, CR was defined the disappearance of all non-target lesions and normalization of tumor marker level for at least 6 weeks. | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with objective evidence of CR, PR or stable disease (SD) determined according to RECIST. For target lesions, stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as a reference the smallest sum of the longest diameters since the treatment started for at least 6 weeks. For non-target lesions, stable disease was defined a persistence of greater than or equal to (>=) 1 non-target lesions and/or maintenance of tumor marker level above the normal limits for at least 6 weeks. |
Not provided
Inclusion Criteria:
Has provided written informed consent.
Has histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography [CT] scan).
Is able to take medications orally.
Is 18 years of age or older.
Has a Karnofsky Performance Status (KPS) ≥ 70%.
Has a life expectancy of ≥ 12 weeks.
Has adequate organ function as defined by the following criteria:
Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
Has had treatment with any of the following within the specified time frame prior to study drug administration:
Major surgery within the previous 3 weeks.
Symptomatic brain metastasis not controlled by corticosteroids.
Leptomeningeal metastasis.
Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer.
Uncontrolled ascites requiring drainage at least twice a week.
Other serious illness or medical condition(s) including, but not limited to, the following:
Is receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
Is a pregnant or lactating female.
Has known sensitivity to 5-FU.
Is a patient with reproductive potential who refuses to use an adequate means of contraception (including male patients).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Taiho Central | Taiho Oncology, Inc. | Study Director |
Not provided
The enrollment of Stage 2 of the study was not initiated, as sufficient efficacy per protocol was not demonstrated in Stage 1. Overall, 29 participants were screened, of them 28 participants were enrolled and 27 received study treatment in Stage 1.
The study was conducted at 9 centers in the Germany between 09-January-2006 to 08-July-2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | S-1 30 mg/m^2 | Participants received 30 milligrams per meter square (mg/m^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who had received at least one dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | S-1 30 mg/m^2 | Participants received 30 mg/m^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first. |
| 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 Tumor Response Rate (ORR) | ORR was defined as the percentage of participants with objective evidence of partial response (PR) or complete response (CR) and was based on the best overall response across all cycles for each participant. Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST). For target lesions response, CR was defined as the disappearance of all target lesions for at least 3 weeks and PR was defined as at least a 30% reduction in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum of the longest diameters for at least 6 weeks. For non-target lesions, CR was defined the disappearance of all non-target lesions and normalization of tumor marker level for at least 6 weeks. | Primary efficacy population included all participants in the safety population who met the key eligibility criteria (1st line therapy in participants with measurable pancreatic locally advanced or metastatic disease) and had at least one response assessment after starting study treatment. Here, 'Number analyzed' signifies number of participants in the specified population. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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 | S-1 30 mg/m^2 | Participants received 30 mg/m^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
Since the pre-defined tumor response futility criteria was not exceeded in Stage 1, participant enrollment for Stage 2 was not conducted, as pre-planned in the protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho | Taiho Oncology, Inc | +1 844-878-2446 | medicalinformation@taihooncology.com |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
| Duration of Response (DR) | DR was calculated as date of first progressive disease (PD) or death, date after the first response of CR or PR minus date of first CR or PR plus 1. Participants who did not die and were without progressive disease were censored at last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method. | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
| Time to Tumor Progression (TTP) | TTP was calculated as date of first PD minus date of first dose of study medication plus 1. Participants without progressive disease were censored at last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method. | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
| Overall Survival (OS) | OS was calculated as date of death minus date of first dose of study medication plus 1. In the absence of death confirmation, OS was censored at the date of last study follow-up. Analysis was performed by Kaplan-Meier method. | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
| Progression-free Survival (PFS) | PFS was defined as date of first PD or date of death minus date of first dose of study medication plus 1. Participants who did not die and were without PD were censored at their last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method. | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
| Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score | KPS classified participant's as per their functional impairment. The KPS ranged from 0percent (%) to 100%, (100= no signs of disease, 90% = few symptoms or signs of disease, 80%=some symptoms or signs, 70% = not capable of normal activity or work, 60% = can take care of most personal requirements, 50% = requires frequent medical care, 40% = disabled, 30% = severely disabled, hospital admission indicated but no risk of death, 20% = very ill, requires supportive measures or treatment, 10% = moribund, rapidly progressive fatal disease processes, and 0% = death), where higher values represented better outcomes. Participants with baseline KPS >=70% were included in study. Final assessment was the participant's last assessment. Participants with available data were only presented in the below data table. | Baseline, at end of treatment (up to 2 years 5 months) |
| Change From Baseline in Pain Intensity | Pain intensity was graded from 0 (least possible pain) to 100 (worst possible pain) on a visual analog scale (VAS). The higher score on VAS scale indicated more pain. Final assessment was the last assessment of participant's. | Baseline, at end of treatment (up to 2 years 5 months) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | An AE was defined as any untoward medical event in a participants administered any dose of a study medication which may or may not have a causal relationship with the use of the study medication. An SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. | From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months) |
| Withdrawal of Consent |
|
| Enrolled but not treated |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants with objective evidence of CR, PR or stable disease (SD) determined according to RECIST. For target lesions, stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as a reference the smallest sum of the longest diameters since the treatment started for at least 6 weeks. For non-target lesions, stable disease was defined a persistence of greater than or equal to (>=) 1 non-target lesions and/or maintenance of tumor marker level above the normal limits for at least 6 weeks. | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants in the specified population. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
|
|
|
| Secondary | Duration of Response (DR) | DR was calculated as date of first progressive disease (PD) or death, date after the first response of CR or PR minus date of first CR or PR plus 1. Participants who did not die and were without progressive disease were censored at last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method. | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants evaluable in specified category. | Posted | Median | 95% Confidence Interval | months | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
|
|
|
| Secondary | Time to Tumor Progression (TTP) | TTP was calculated as date of first PD minus date of first dose of study medication plus 1. Participants without progressive disease were censored at last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method. | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was calculated as date of death minus date of first dose of study medication plus 1. In the absence of death confirmation, OS was censored at the date of last study follow-up. Analysis was performed by Kaplan-Meier method. | Analysis was performed on safety population that included all the participants who had received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as date of first PD or date of death minus date of first dose of study medication plus 1. Participants who did not die and were without PD were censored at their last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method. | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants in the specified population. | Posted | Median | 95% Confidence Interval | months | From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months |
|
|
|
| Secondary | Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score | KPS classified participant's as per their functional impairment. The KPS ranged from 0percent (%) to 100%, (100= no signs of disease, 90% = few symptoms or signs of disease, 80%=some symptoms or signs, 70% = not capable of normal activity or work, 60% = can take care of most personal requirements, 50% = requires frequent medical care, 40% = disabled, 30% = severely disabled, hospital admission indicated but no risk of death, 20% = very ill, requires supportive measures or treatment, 10% = moribund, rapidly progressive fatal disease processes, and 0% = death), where higher values represented better outcomes. Participants with baseline KPS >=70% were included in study. Final assessment was the participant's last assessment. Participants with available data were only presented in the below data table. | Analysis was performed on safety population that included all the participants who had received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline, at end of treatment (up to 2 years 5 months) |
|
|
|
| Secondary | Change From Baseline in Pain Intensity | Pain intensity was graded from 0 (least possible pain) to 100 (worst possible pain) on a visual analog scale (VAS). The higher score on VAS scale indicated more pain. Final assessment was the last assessment of participant's. | Analysis was performed on safety population that included all the participants who had received at least one dose of study medication. | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline, at end of treatment (up to 2 years 5 months) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | An AE was defined as any untoward medical event in a participants administered any dose of a study medication which may or may not have a causal relationship with the use of the study medication. An SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. | Analysis was performed on safety population that included all the participants who had received at least one dose of study medication. | Posted | Count of Participants | Participants | From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months) |
|
|
|
| 24 |
| 27 |
| 15 |
| 27 |
| 25 |
| 27 |
| Ascites | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pancreatic insufficiency | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vitamin k deficiency | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
|
|
|
|
|
| Baseline score 100% shift to Final assessment score 0% |
|
| Baseline score 90% shift to Final assessment score 90% |
|
| Baseline score 90% shift to Final assessment score 80% |
|
| Baseline score 90% shift to Final assessment score 70% |
|
| Baseline score 90% shift to Final assessment score 60% |
|
| Baseline score 90% shift to Final assessment score 0% |
|
| Baseline score 80% shift to Final assessment score 80% |
|
| Baseline score 80% shift to Final assessment score 0% |
|
| Baseline score 70% shift to Final assessment score 0% |
|