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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1177-7929 | Registry Identifier | WHO |
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This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute (NCI) Organ Dysfunction Working Group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IXAZOMIB Arm 1 | Experimental | Experimental: Arm 1 (Normal hepatic function) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 4 mg dose of IXAZOMIB capsule on Day 1. Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle |
|
| IXAZOMIB Arm 2 | Experimental | Experimental: Arm 2 (Moderate hepatic impairment) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 2.3 mg dose of IXAZOMIB capsule on Day 1. Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle |
|
| IXAZOMIB Arm 3 | Experimental | Experimental: Arm 3 (Severe hepatic impairment) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 1.5 mg dose of IXAZOMIB capsule on Day 1. Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IXAZOMIB | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib | Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose | |
| Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib | Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose | |
| Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles]) |
| Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. | Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles) |
| Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairway | Kansas | United States | ||||
Participants with diagnosis of advanced solid tumors or hematologic malignancies having varying degrees of liver dysfunction enrolled in 1 of 3 treatment groups to receive ixazomib 4 mg (normal hepatic function), 2.3 mg (moderate impairment), 1.5 mg (severe impairment) on Day 1 (Part A, 15 day cycle) and on Days 1,8 and 15(Part B, 28 day cycle).
Participants took part in the study at 4 investigative sites in the United States from 27 August 2013 to 25 March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Hepatic Function (Ixazomib 4 mg) | Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function. |
| FG001 | Moderate Hepatic Impairment (Ixazomib 2.3 mg) | Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment. |
| FG002 | Severe Hepatic Impairment (Ixazomib 1.5 mg) | Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Pharmacokinetic Period |
|
| ||||||||||||||||||
| Part B: Treatment Period |
|
The safety analysis population was defined as participants who received at least 1 dose of ixazomib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Hepatic Function (Ixazomib 4 mg) | Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function. |
| BG001 | Moderate Hepatic Impairment (Ixazomib 2.3 mg) |
| 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 | Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib | The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods. | Posted | Geometric Mean | Standard Deviation | nanogram*hours per milliliter (ng*hr/mL) | Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (up to cycle 12 [each cycle is 28 days]).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 | Normal Hepatic Function (Ixazomib 4 mg) | Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-866-835-2233 | GlobalOncologyMedinfo@takeda.com |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
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| ID | Term |
|---|---|
| C548400 | ixazomib |
Not provided
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Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). |
| Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles) |
| Cleveland |
| Ohio |
| United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| NOT COMPLETED |
|
|
Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment. |
| BG002 | Severe Hepatic Impairment (Ixazomib 1.5 mg) | Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Disease type at diagnosis | Solid tumor includes colon, colorectal, endometrial, esophageal, gall bladder, head and neck, kidney, liver, melanoma, mesothelioma, non-small cell lung cancer, ovarian, pancreatic, prostate, rectal, and sarcoma. Other tumor includes cholangiocarcinoma, malignant fibrous histiocytoma, metastatic poorly differentiated squamous cell carcinoma of the pelvis, moderately differentiated adenocarcinoma compatible with intrahepatic cholangiocarcinoma, unknown primary with liver metastasis, and peritoneal adenocarcinoma. | Number | participants |
|
| Months from initial diagnosis to first dose of ixazomib | Mean | Standard Deviation | months |
|
| Participants with prior antineoplastic therapy | All participants had prior antineoplastic therapy. | Number | participants |
|
| Participant with prior radiation | Number | participants |
|
| Participant with prior surgery | Number | participants |
|
| Baseline Eastern Cooperative Oncology Group (ECOG) performance status | ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Participants who had a score of 0 or 1 were assessed. | Number | participants |
|
| Baseline total bilirubin | Mean | Standard Deviation | micro mole per liter (mcmol/L) |
|
| Baseline aspartate aminotransferase (AST) | Mean | Standard Deviation | units per liter (U/L) |
|
| OG001 | Moderate Hepatic Impairment (Ixazomib 2.3 mg) | Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment. |
| OG002 | Severe Hepatic Impairment (Ixazomib 1.5 mg) | Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment. |
|
|
| Primary | Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib | The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose |
|
|
|
| Primary | Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib | The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods. | Posted | Median | Full Range | hours | Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose |
|
|
|
| Primary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | The safety analysis population was defined as participants who received at least 1 dose of ixazomib. | Posted | Number | participants | Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles]) |
|
|
|
| Primary | Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. | The safety analysis population was defined as participants who received at least 1 dose of ixazomib. | Posted | Number | participants | Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles) |
|
|
|
| Primary | Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs | Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). | The safety analysis population was defined as participants who received at least 1 dose of ixazomib. | Posted | Number | participants | Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles) |
|
|
|
| 6 |
| 13 |
| 12 |
| 13 |
| EG001 | Moderate Hepatic Impairment (Ixazomib 2.3 mg) | Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment. | 10 | 15 | 14 | 15 |
| EG002 | Severe Hepatic Impairment (Ixazomib 1.5 mg) | Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment. | 15 | 20 | 17 | 20 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 2.3 mg treatment arm. |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participants in ixazomib 2.3 mg treatment arm and three study participants in ixazomib 1.5 mg treatment arm. |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 2.3 mg treatment arm and one study participant in ixazomib 1.5 mg treatment arm. |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 1.5 mg treatment arm. |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 1.5 mg treatment arm. |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 2.3 mg treatment arm. |
|
| Metastases to central nervous system | 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 | The occurrence of this event led to death of one study participant in ixazomib 1.5 mg treatment arm. |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 1.5 mg treatment arm. |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 2.3 mg treatment arm. |
|
| Device related infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (16.0) | Systematic Assessment | The occurrence of this event led to death of one study participant in ixazomib 2.3 mg treatment arm. |
|
| Mental status changes | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Ammonia increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Waist circumference increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (16.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| Title | Measurements |
|---|---|
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