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This research study will evaluate the effectiveness and estimate the feasibility of administering an investigational drug called 'CN-105' (the study drug), to prevent postoperative cognitive decline, delirium (serious confusion) and underlying brain inflammatory and brain activity changes in adults 60 years and older undergoing surgery.
This research study will evaluate the effectiveness and estimate the feasibility of administering an investigational drug called 'CN-105' (the study drug), to prevent postoperative cognitive decline, delirium (serious confusion) and underlying brain inflammatory and brain activity changes in adults 60 years and older undergoing surgery. The word "investigational" means the study drug is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
It is hoped that CN-105 will block signaling via a gene known as ApoE4, the most common gene implicated in late life Alzheimer's disease.
Depending on when patients enroll in this study, participants will receive either a placebo or a progressively higher dose of CN-105 until the safest and best tolerated dose is reached. The study drug is given via IV (intravenous, meaning through a vein) infusion in the hospital. Study drug infusions will be given up to 4 days after surgery.
Participants will also perform memory and thinking tests, as well as complete a survey and functional assessments, both prior to surgery and again 6 weeks after surgery. Each of those research visits will last about 1 hour.
Additionally, the investigators will collect a blood sample and a cerebrospinal fluid (CSF) sample prior to the participant's surgery, 24 hours after surgery, and again 6 weeks after surgery. To obtain the CSF (cerebrospinal fluid) sample, investigators will perform a lumbar (the lower part of the spinal column) puncture. During surgery, investigators will also record participant brain waves from the scalp using an EEG (electroencephalography) monitor. An electroencephalography monitor reads the electrical activity of the brain in different places using a cap with sensors that is worn on the head.
Although previous studies have not found any associations between the study drug and any serious medical problems, investigators will monitor its effect on wound healing and postoperative infections.
Benefits of this study include the possibility of fewer problems in thinking and memory after surgery if this study drug works as hoped.
Risks of participation in this study include headache, infection/discomfort from the lumbar puncture, discomfort from the blood draw, and minor skin irritation or redness from the EEG and heart rate monitor procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CN-105 | Experimental | Cohort 1: 50 Patients Dose of CN-105: 0.1 mg/kg Cohort 2: 50 Patients Dose of CN-105: 0.5 mg/kg Cohort 3: 50 Patients Dose of CN-105: 1 mg/kg |
|
| Placebo | Placebo Comparator | Cohort 1: 17 Patients receiving placebo Cohort 2: 17 Patients receiving placebo Cohort 3: 17 Patients receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CN-105 | Drug | Three doses of CN-105 will be used in three successive cohorts of 50 patients each. 0.1 mg/kg (cohort 1), 0.5 mg/kg (cohort 2), 1 mg/kg (cohort 3) The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) of Grade II or Higher Per Patient | Safety of CN-105 administration, as measured by adverse event (AE) rates of Grade II and higher in CN-105 versus placebo-treated patients. | up to 6-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebrospinal Fluid (CSF) IL-6 Cytokine Levels Between Drug vs Placebo Treated Patients | Change in CSF IL-6 cytokine levels from before to after surgery between drug vs placebo treated patients. | Baseline, 24 hours, approximately 6 weeks |
| Change in CSF IL-8 Cytokine Levels Between Drug vs Placebo Treated Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miles Berger, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41931297 | Derived | Timko NJ, Cooter Wright M, Smith MR, Boykin PC, Emerson JM, Woldorff MG, Eleswarpu S, Herbert JT, Moretti EW, Devinney MJ, Ayoub CM, Rockhold FW, Ryu D, Syed A, VanDusen KW, Bunning T, Hsia BJ, Bolognesi MP, Jiranek WA, Zetterberg H, Blennow K, Huebner JL, Li Z, Reekes TH, Browndyke JN, Laskowitz DT, Berger M; MARBLE Study Investigators. Apolipoprotein E Mimetic Peptide CN-105 and Postoperative Delirium in Older Patients: The Phase 2 MARBLE Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e262289. doi: 10.1001/jamanetworkopen.2026.2289. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CN-105 | The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses. |
| FG001 | Placebo | Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | CN-105 | The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses. |
| BG001 | Placebo |
| 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 Adverse Events (AEs) of Grade II or Higher Per Patient | Safety of CN-105 administration, as measured by adverse event (AE) rates of Grade II and higher in CN-105 versus placebo-treated patients. | Participants who completed the study. | Posted | Median | Inter-Quartile Range | events per participant | up to 6-week follow-up |
|
Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
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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 | CN-105 | The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL MASS | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miles Berger, MD, PhD | Duke University | 919-684-8679 | miles.berger@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2022 | Jun 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D000079690 | Postoperative Cognitive Complications |
| D003693 | Delirium |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000712807 | apolipoprotein E mimetic peptide CN-105 |
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Investigators will enroll 201 patients total in this phase 2 escalating dose study, with escalating CN-105 doses occurring in three successive groups of 67 patients each. In each group of 67 patients, 50 will receive a given dose of CN-105 and 17 will receive placebo.
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Participants will be randomized to receive either CN-105 or placebo after they consent to participate in the trial. Participants will be enrolled in 1 of 3 dose cohorts of 67 subjects each. An independent statistician will prepare dose stratified mixed block size randomization lists in a 3 to 1 ratio to achieve the desired distribution of drug and placebo. In each block of 67 trial participants, 50 will receive CN-105 and 17 will receive placebo, in a double-blind fashion.
CN-105 and placebo will be prepared in identical bags labelled simply with the trial participant's number (1-201) to keep all trial staff and clinicians blinded to randomization. Only the investigational pharmacist will have the randomization list for each participant showing what dose of CN-105 or placebo will be administered. To minimize bias, investigators conducting the laboratory assays on the CSF and blood samples will be blinded to trial group assignment during the course of the trial.
|
| Placebo | Drug | Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug. |
|
Change in CSF IL-8 cytokine levels from before to after surgery between drug vs placebo treated patients |
| Baseline, 24 hours, approximately 6 weeks |
| Change in CSF MCP-1 Cytokine Levels Between Drug vs Placebo Treated Patients | Change in CSF MCP-1 cytokine levels before to after surgery between drug vs placebo treated patients | Baseline, 24 hours, approximately 6 weeks |
| Change in CSF G-CSF Cytokine Levels Between Drug vs Placebo Treated Patients | Change in CSF G-CSF cytokine levels before to after surgery between drug vs placebo treated patients. | Baseline, 24 hours, approximately 6 weeks |
| Change in Cognitive Change Index (CCI) Between Drug vs Placebo Treated Patients | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a Z-score standardization was performed on the 11 cognitive test scores with mean and standard deviation derived at the baseline timepoint. We then constructed four summary scores by taking the average of the standardized cognitive test scores, which represent the following cognitive domains: verbal memory, executive function, visual memory and attention. To quantify overall cognitive function, a cognitive index was calculated as the mean of the 4 domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.33. A negative change score indicating decline and a positive score indicating improvement. | Baseline, approximately 6 weeks |
| Feasibility of Drug Administration as Measured by the Percentage of Doses Given Within the Correct Time Window | The feasibility of perioperative CN-105 administration is assessed by tracking the percentage of doses given within the correct time window (i.e. within 1 hour prior to the scheduled or actual start time of the surgery, and within a +/- 90 minute time window for subsequent doses, which are administered every 6 hours after the start of surgery). | admission to preoperative holding to hospital discharge (up to postoperative day 4) |
| Number of Participants Who Experience Delirium | Scores on 3D CAM (non-intubated patients) or CAM ICU (intubated patients) are used to determine whether patients have delirium (yes/no). | Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeks |
| Peak Severity of Delirium Symptoms Between Drug vs. Placebo Treated Patients | Scores on the 3D CAM (in non-intubated patients) are used to determine delirium symptom severity based on a 0 - 20 point scale of the test. Higher scores indicate worse delirium. | Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeks |
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Change in Cerebrospinal Fluid (CSF) IL-6 Cytokine Levels Between Drug vs Placebo Treated Patients | Change in CSF IL-6 cytokine levels from before to after surgery between drug vs placebo treated patients. | Participants with data collected at each timepoint. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline, 24 hours, approximately 6 weeks |
|
|
|
|
| Secondary | Change in CSF IL-8 Cytokine Levels Between Drug vs Placebo Treated Patients | Change in CSF IL-8 cytokine levels from before to after surgery between drug vs placebo treated patients | Participants with data collected at each timepoint. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline, 24 hours, approximately 6 weeks |
|
|
|
|
| Secondary | Change in CSF MCP-1 Cytokine Levels Between Drug vs Placebo Treated Patients | Change in CSF MCP-1 cytokine levels before to after surgery between drug vs placebo treated patients | Participants with data collected at each timepoint. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline, 24 hours, approximately 6 weeks |
|
|
|
|
| Secondary | Change in CSF G-CSF Cytokine Levels Between Drug vs Placebo Treated Patients | Change in CSF G-CSF cytokine levels before to after surgery between drug vs placebo treated patients. | Participants who had data collected at each timepoint. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline, 24 hours, approximately 6 weeks |
|
|
|
|
| Secondary | Change in Cognitive Change Index (CCI) Between Drug vs Placebo Treated Patients | To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a Z-score standardization was performed on the 11 cognitive test scores with mean and standard deviation derived at the baseline timepoint. We then constructed four summary scores by taking the average of the standardized cognitive test scores, which represent the following cognitive domains: verbal memory, executive function, visual memory and attention. To quantify overall cognitive function, a cognitive index was calculated as the mean of the 4 domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.33. A negative change score indicating decline and a positive score indicating improvement. | Participants who completed both baseline and 6-week follow-up visit and surgery on protocol. | Posted | Mean | Standard Deviation | units on a scale | Baseline, approximately 6 weeks |
|
|
|
|
| Secondary | Feasibility of Drug Administration as Measured by the Percentage of Doses Given Within the Correct Time Window | The feasibility of perioperative CN-105 administration is assessed by tracking the percentage of doses given within the correct time window (i.e. within 1 hour prior to the scheduled or actual start time of the surgery, and within a +/- 90 minute time window for subsequent doses, which are administered every 6 hours after the start of surgery). | Posted | Mean | 95% Confidence Interval | percentage of doses | admission to preoperative holding to hospital discharge (up to postoperative day 4) |
|
|
|
| Secondary | Number of Participants Who Experience Delirium | Scores on 3D CAM (non-intubated patients) or CAM ICU (intubated patients) are used to determine whether patients have delirium (yes/no). | Participants who completed surgery on protocol and had at least 1 postoperative CAM-3D or CAM-ICU assessment performed. | Posted | Count of Participants | Participants | Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeks |
|
|
|
|
| Secondary | Peak Severity of Delirium Symptoms Between Drug vs. Placebo Treated Patients | Scores on the 3D CAM (in non-intubated patients) are used to determine delirium symptom severity based on a 0 - 20 point scale of the test. Higher scores indicate worse delirium. | Subjects who completed surgery on protocol and had at least 1 postoperative CAM-3D assessment performed. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeks |
|
|
|
|
| 0 |
| 137 |
| 11 |
| 137 |
| 105 |
| 137 |
| EG001 | Placebo | Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug. | 0 | 49 | 11 | 49 | 43 | 49 |
| ANOREXIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| CYSTOSCOPY FOR REMOVAL OF URINARY CATHETER | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| GASTRIC STENOSIS | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| HEART FAILURE EXACERBATION | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| HEMORRHAGE | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOXEMIA | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| INTRAOPERATIVE ARTERIAL INJURY | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| LARYNGEAL EDEMA | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| MEDICAL PROCEDURE | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| MOBITZ TYPE 1 AV BLOCK | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| NEOPLASM (METASTATIC SQUAMOUS CELL LUNG CANCER) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
|
| PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
|
| PHARYNGITIS/OTALGIA | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| POST-OPERATIVE ILEUS | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| ACIDOSIS | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| ALT INCREASED | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| AST INCREASED | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| BLADDER SPASM | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| CEREBROSPINAL FLUID LEAKAGE. | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| CREATININE INCREASE | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| CYSTITIS NONINFECTIVE (VS PROSTATITIS, DYSURIA, PROTEINURIA) | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| DECREASED LYMPHOCYTE COUNT | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| DECREASED PLATELET COUNT | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| DEPRESSION (IE ADJUSTMENT DISORDER WITH ANXIETY AND DEPRESSED MOOD) | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| EGD | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| EPIDIDYMO-ORCHITIS | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
|
| ERYTHEMATOUS AREA NOTED IN THE RIGHT ANTECUBITAL FOSSA | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| ESOPHAGEAL ULCER | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| FASCIAL DEHISCENCE | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| FECAL INCONTINENCE | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| FEVER | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| FLU LIKE SYMPTOMS | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| GASTROESOPHAGEAL REFLUX- | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| HEMATURIA | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| HEMORRHAGE | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| HEMORRHAGE | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| HEMORRHAGE | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| HIGH CHEST TUBE OUTPUT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPERBILIRUBINEMIA | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| HYPERCALCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| INCREASED CREATININE | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| INFECTION | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| INFUSION SITE EXTRAVASATION | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| INR INCREASED | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| IV INFILTRATION | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| JOINT EFFUSION | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| LOW ALBUMIN | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| LOW LYMPH COUNT | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| LOW URINE OUTPUT | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| MALAISE | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| MUCOSITIS ORAL | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| NON-INFECTIVE CYSTITIS | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| OPERATIVE REPAIR OF EVISCERATION OF BOWEL FROM MIDLINE INCISION | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| PAIN | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| PAIN | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| PAIN | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| PAIN | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
|
| PAROTITIS | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| PERMANENT PACEMAKER PLACEMENT | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| POSSIBLE HYPOTHYROIDISM | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
|
| POST-OPERATIVE ATRIAL FIBRILLATION | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| PRURITIS | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| RADICULITIS | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| RIGHT INGUINAL HERNIA | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| SEVERE PROTEIN CALORIE MALNUTRITION | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| SHOULDER INJECTION | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| SINUS TACHYCARDIA | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| TRANSFER TO LONG-TERM CARE FACILITY DUE TO MENTAL ACUITY CONCERN | Social circumstances | CTCAE (5.0) | Systematic Assessment |
|
| UNPLANNED SURGICAL PROCEDURE | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| URINARY URGENCY | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| URINE OUTPUT DECREASED | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| VASCULAR ACCESS COMPLICATION | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| VASOVAGAL REACTION | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| VULVOVAGINAL ATROPHY/VAGINAL DRYNESS | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| WOUND COMPLICATION | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| Baseline to 6 weeks |
|
|
| 0.388 |
| Other |
| Baseline to 6 weeks |
|
|
| 0.047 |
| Other |
| Baseline to 6 weeks |
|
|
| 0.745 |
| Other |
| Baseline to 6 weeks |
|
|
| 0.478 |
| Other |