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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1156-8540 | Registry Identifier | WHO |
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The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).
At the end of the study, eligible participants could enroll and receive treatment and follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004 were followed by telephone contact at 6-month intervals for 2 years after the last administration of study treatment to collect reports of adverse events, including colectomy, severe infections [including progressive multifocal leukoencephalopathy (PML)], and dysplasia/cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Vedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85. |
|
| Vedolizumab 2 mg/kg | Experimental | Vedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85. |
|
| Vedolizumab 6 mg/kg | Experimental | Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85. |
|
| Vedolizumab 10 mg/kg | Experimental | Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Drug | Vedolizumab for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with normal daily activities Severe: Inability to perform normal daily activities. | From the first date of study drug administration through Day 253 |
| Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85 | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing. |
| Cmin: Minimum Observed Plasma Concentration of Vedolizumab | Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing. |
| Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab | AUC was calculated for 3 time intervals during the study:
|
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Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study.
Males or non-pregnant, non-lactating females voluntarily able to give informed consent
All patients must agree to use 2 effective forms of contraception from screening to the end of the study
Negative surveillance colonoscopy within the last 6 months if indicated by standard clinical practice guidelines
Confirmed and active ulcerative colitis (UC)
May be receiving a therapeutic dose of conventional therapies for UC as defined by the protocol
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26893500 | Derived | Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18. | |
| 25996351 | Derived |
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Participants with active ulcerative colitis were randomized in a 4:1 ratio of vedolizumab to placebo.
Participants took part in the study at 2 study centers in Canada and 9 study centers in Russia, from 02 May 2007 to 16 June 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85. |
| FG001 | Vedolizumab 2 mg/kg | Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85. |
| FG002 | Vedolizumab 6 mg/kg | Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85. |
| FG003 | Vedolizumab 10 mg/kg | Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline measures are reported for the Safety Analysis Set - all enrolled participants who received at least 1 dose of study treatment. One participant was randomized but not dosed and is not included in this population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85. |
| BG001 | Vedolizumab 2 mg/kg | Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with normal daily activities Severe: Inability to perform normal daily activities. | Safety Analysis Set, defined as all enrolled participants who received at least 1 dose of study treatment. One participant was randomized but not dosed and is not included in this population. | Posted | Number | participants | From the first date of study drug administration through Day 253 |
Adverse events were collected through Day 253 or the final study visit.
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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 | Placebo | Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Millennium Pharmaceuticals Inc | 1-800-778-2860 | clinicaltrialregistry@tpna.com |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543529 | vedolizumab |
| C438271 | LDP-02 |
Not provided
Not provided
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| Placebo | Drug | Placebo intravenous infusion |
|
| Days 0-14, Days 85-99, Days 85-141 |
| Terminal Phase Elimination Half-life (t½) of Vedolizumab | Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma. | Pre-dose through Day 253 |
| Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker | The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the Act-1 binding interference assay. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percent inhibition of the Act-1 due to the presence of vedolizumab binding. Emax was calculated on Day 1, Day 85 and based on all available data. | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
| Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker | The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percent inhibition of the MAdCAM-1-Fc binding to α4β7 integrin due to the presence of vedolizumab binding. Emax was calculated on Day 1, Day 85, and based on all available data. | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
| Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker | AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the Act-1 marker. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
| Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker | AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the MAdCAM-1-Fc marker. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
| Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20. |
| Worsening disease activity |
|
| Withdrawal by Subject |
|
| BG002 | Vedolizumab 6 mg/kg | Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85. |
| BG003 | Vedolizumab 10 mg/kg | Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
| Body Surface Area (BSA) | Mean | Standard Deviation | m² |
|
| Time Since Onset of Symptoms | Mean | Standard Deviation | years |
|
| Time Since Diagnosis | Mean | Standard Deviation | years |
|
| Participants with Acute Exacerbations in Past 12 Months | Number | participants |
|
| Participants Hospitalized for UC in Past 12 Months | Number | participants |
|
| Participants with Ongoing Therapy for UC at Enrollment | Number | participants |
|
| Participants with Significant Medical Conditions in Past 6 Months | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Placebo | Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85. |
| OG001 | Vedolizumab 2 mg/kg | Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85. |
| OG002 | Vedolizumab 6 mg/kg | Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85. |
| OG003 | Vedolizumab 10 mg/kg | Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85. |
|
|
| Primary | Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85 | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Pharmacokinetic (PK) Analysis Set, defined as all vedolizumab participants for whom there were sufficient data to estimate PK. Analyses only include participants with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | µg/mL | Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing. |
|
|
|
| Primary | Cmin: Minimum Observed Plasma Concentration of Vedolizumab | Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | PK Analysis Set; participants with available data. | Posted | Mean | Standard Deviation | μg/mL | Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing. |
|
|
|
| Primary | Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab | AUC was calculated for 3 time intervals during the study:
| PK Analysis Set; participants with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | day*μg/mL | Days 0-14, Days 85-99, Days 85-141 |
|
|
|
| Primary | Terminal Phase Elimination Half-life (t½) of Vedolizumab | Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma. | PK Analysis Set; participants with available data | Posted | Mean | Standard Deviation | days | Pre-dose through Day 253 |
|
|
|
| Primary | Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker | The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the Act-1 binding interference assay. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percent inhibition of the Act-1 due to the presence of vedolizumab binding. Emax was calculated on Day 1, Day 85 and based on all available data. | Pharmacodynamic (PD) Analysis Set, defined as all participants for whom there were sufficient data to estimate PD. Analyses only include participants with available data (indicated by "n"). | Posted | Mean | Standard Deviation | percent inhibition | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
|
|
|
| Primary | Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker | The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percent inhibition of the MAdCAM-1-Fc binding to α4β7 integrin due to the presence of vedolizumab binding. Emax was calculated on Day 1, Day 85, and based on all available data. | PD Analysis Set; participants with available data (indicated by "n") | Posted | Mean | Standard Deviation | percent inhibition | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
|
|
|
| Primary | Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker | AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the Act-1 marker. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. | PD Analysis Set; participants with available data (indicated by "n") | Posted | Mean | Standard Deviation | percent inhibition*days | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
|
|
|
| Primary | Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker | AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the MAdCAM-1-Fc marker. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. | PD Analysis Set; participants with available data (indicated by "n") | Posted | Mean | Standard Deviation | percent inhibition*days | Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253 |
|
|
|
| 0 |
| 9 |
| 7 |
| 9 |
| EG001 | Vedolizumab 2 mg/kg | Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85. | 1 | 12 | 9 | 12 |
| EG002 | Vedolizumab 6 mg/kg | Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85. | 0 | 14 | 9 | 14 |
| EG003 | Vedolizumab 10 mg/kg | Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85. | 1 | 11 | 6 | 11 |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Laryngotracheitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Anal discomfort | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (9.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (9.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (9.1) | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (9.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Breast adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
|
|
| AUC(Day 85-141) (n=9, 14, 11) |
|
| Day 85 (n=8, 9, 12, 11) |
|
| All available (n=8, 10, 12, 11) |
|
| Day 85 (n=8, 9, 11, 10) |
|
| All available (n=8, 10, 11, 10) |
|