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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002070-51 | EudraCT Number |
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The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retifanlimab 500 mg | Experimental | Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retifanlimab | Drug | Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| UC Davis Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35816951 | Result | Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, Saunders MP, Gilbert DC, Jensen LH, Samalin E, Spindler KL, Tamberi S, Demols A, Guren MG, Arnold D, Fakih M, Kayyal T, Cornfeld M, Tian C, Catlett M, Smith M, Spano JP. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529. doi: 10.1016/j.esmoop.2022.100529. Epub 2022 Jul 8. |
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A total of 94 participants with locally advanced or metastatic squamous carcinoma of the anal canal were enrolled in the study and treated with retifanlimab.
This study was conducted at 40 study centers: 32 in France, 19 in the United Kingdom, 10 in Italy, 10 in Spain, 7 in Denmark, 6 in the United States, 4 in Norway, 4 in Belgium, and 2 in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retifanlimab 500 mg | Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2019 | Jun 4, 2021 |
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| up to 18.2 months |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, at any post-baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months |
| Progression-free Survival (PFS) | According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, as determined by ICR, or death due to any cause, if occurring sooner than progression. | up to 16.8 months |
| Overall Survival | Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause. | up to 28.2 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab. | up to 913 days |
| Cmax of Retifanlimab | Cmax was defined as the maximum observed plasma concentration. | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
| Tmax of Retifanlimab | tmax was defined as the time to the maximum concentration. | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
| Cmin of Retifanlimab | Cmin was defined as the minimum observed plasma concentration over the dose interval. | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
| AUC0-t of Retifanlimab | AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
| Sacramento |
| California |
| 95817 |
| United States |
| Ridley-Tree Cancer Center | Santa Barbara | California | 95817 | United States |
| Maryland Oncology Hematology P.A. | Rockville | Maryland | 20850 | United States |
| Texas Oncology-Baylor Charles A. Sammons | Dallas | Texas | 75246 | United States |
| Texas Oncology-McKinney | McKinney | Texas | 75071 | United States |
| Renovatio Clinical | Spring | Texas | 77380 | United States |
| Zna Middelheim | Antwerp | 2020 | Belgium |
| Hopital Erasme | Brussels | 1070 | Belgium |
| Aarhus Universitets Hospital | Aarhus | 8000 | Denmark |
| Herlev Og Gentofte Hospital | Herlev | 2730 | Denmark |
| Vejle Hospital | Vejle | 7100 | Denmark |
| Centre Hospitalier Universitaire de Besancon | Besançon | 2500 | France |
| CHU Hopital De La Timone | Marseille | 13385 | France |
| Icm Montpellier | Montpellier | 34298 | France |
| Hopital Universitaire Pitie-Salpetriere | Paris | 75013 | France |
| Chu de Rennes - Hôpital Pontchaillou | Rennes | 35033 | France |
| Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau | Saint-Herblain | 44805 | France |
| CHU Toulouse Hopital Rangueil | Toulouse | 31059 | France |
| University Medical Centre Hamburg-Eppendorf, Centre of Oncology | Hamburg | 20246 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Ancona | 60126 | Italy |
| Ospedale A. Perrino - Brindisi | Brindisi | 72100 | Italy |
| A.O.U. Policlinico V. Emanuele G. Rodolico | Catania | 95123 | Italy |
| Ospedale Degli Infermi - Faenza | Faenza | 48018 | Italy |
| Irccs Azienda Ospedaliera Universitaria San Martino | Genova | 16132 | Italy |
| Niguarda Cancer Center | Milan | 20162 | Italy |
| Aou Modena - Policlinico | Modena | 41124 | Italy |
| Clinica La Maddalena | Palermo | 90146 | Italy |
| Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore | Rome | 00168 | Italy |
| IRCCS Casa Sollievo Della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| Haukeland U Hospital Bergen | Bergen | 5021 | Norway |
| Oslo U | Oslo | 0450 | Norway |
| Hospital General Universitari Vall D Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| Royal Marsden Hospital | Chelsea | SW3 6JJ | United Kingdom |
| Castle Hill Hospital | Cottingham | HU16 5JQ | United Kingdom |
| St. James U Hospital | Leeds | L59 7TF | United Kingdom |
| St. James Univ Hospital | Leeds | L59 7TF | United Kingdom |
| Royal Free London Nhs Foundation Trust | London | NW3 2QG | United Kingdom |
| The Royal Marsden Nhs Foundation Trust - Chelsea | London | SW3 6JI | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BV | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Royal Cornwall Hospital, Sunrise Centre | Truro | TR1 3LQ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of study drug.
| ID | Title | Description |
|---|---|---|
| BG000 | Retifanlimab 500 mg | Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| 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 | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of study drug | Posted | Number | percentage of participants | Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | Full Analysis Set. All participants with confirmed tumor responses (CR or PR) by ICR according to RECIST v1.1 were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation. | Posted | Median | 95% Confidence Interval | months | up to 18.2 months |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, at any post-baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, as determined by ICR, or death due to any cause, if occurring sooner than progression. | Full Analysis Set. Median PFS time was estimated using the Kaplan-Meier method. The confidence interval for median PFS time was calculated using the method of Brookmeyer and Crowley. | Posted | Median | 95% Confidence Interval | months | up to 16.8 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause. | Full Analysis Set. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Posted | Median | 95% Confidence Interval | months | up to 28.2 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab. | Safety Evaluable Population: all enrolled participants who received at least 1 dose of study drug | Posted | Count of Participants | Participants | up to 913 days |
|
| |||||||||||||||||||||||||||
| Secondary | Cmax of Retifanlimab | Cmax was defined as the maximum observed plasma concentration. | Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and provided a Baseline and at least 1 postdose serum sample (1 PK measurement) | Posted | Mean | Standard Deviation | milligrams per Liter (mg/L) | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Tmax of Retifanlimab | tmax was defined as the time to the maximum concentration. | PK Evaluable Population | Posted | Mean | Standard Deviation | hours | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Cmin of Retifanlimab | Cmin was defined as the minimum observed plasma concentration over the dose interval. | PK Evaluable Population | Posted | Mean | Standard Deviation | mg/L | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
|
| ||||||||||||||||||||||||||
| Secondary | AUC0-t of Retifanlimab | AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. | PK Evaluable Population | Posted | Mean | Standard Deviation | day*mg/L | pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6 |
|
|
up to 913 days
Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
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 | Retifanlimab 500 mg | Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W). | 60 | 94 | 50 | 94 | 79 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coma hepatic | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inadequate analgesia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Proctitis haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Superior mesenteric artery syndrome | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Tumour embolism | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Ureteric compression | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
Clinical Study Agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Incyte | 1.855.463.3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2019 | Jun 4, 2021 | SAP_001.pdf |
Not provided
| Not Reported |
|
| Unknown |
|
| Missing |
|
| Captured as "Other" |
|
| Missing |
|
| Not Reported |
|
|
|
|
|
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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