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| Name | Class |
|---|---|
| Immune Oncology Network (ION) | UNKNOWN |
Not provided
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The primary objective of this study was to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with HNSCC who had previously received anti-PD-(L)1 therapy but who had not achieved a CR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Nemvaleukin 3 mcg/kg + Pembrolizumab 200 mg | Experimental | Participants with current stable disease (SD) or partial response (PR) (Cohorts 1 and 2) who were not progressing or further demonstrating reductions in tumor size were to receive nemvaleukin alfa 3 microgram per kilogram (mcg/kg), intravenous (IV) infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 milligram (mg), IV infusion, once, every three weeks (Q3W) on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
|
| Group 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Experimental | Participants with progressive disease (PD) (Cohorts 3 and 4) received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemvaleukin Alfa | Drug | Nemvaleukin alfa IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Based on RECIST v1.1 | ORR was defined as percentage of participants with complete response (CR) or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | From the first dose of study drug until first PD or death, whichever occurred first (up to 49 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Based on RECIST v1.1 | DOR was defined as time in months from the first documentation CR or PR until the first documentation of confirmed PD as assessed by investigator based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Mural Oncology, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mural Oncology Investigational Site | Miami | Florida | 33136 | United States | ||
| Mural Oncology Investigational Site |
This study consisted of Group 1 (Cohorts 1 and 2) and Group 2 (Cohorts 3 and 4). Group 1 was closed due to lack of recruitment of eligible participants and therefore, no data for Group 1 (Cohorts 1 and 2) were collected, analyzed or reported. Data was collected and analyzed for Group 2 and is presented in this results report.
Participants took part in the study at 7 investigative sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck (HNSCC) and with progressive disease (PD) with no prior response to greater than or equal to (>=) 8 weeks anti programmed cell death ligand-1 (anti-PD-[L]1) therapy received nemvaleukin alfa 3 microgram per kilogram (mcg/kg), intravenous (IV) infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 milligram (mg), IV infusion, once, every three weeks (Q3W) on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| FG001 | Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response stable disease (SD) or partial response (PR) and after >=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included participants who received at least one dose of either study drug (nemvaleukin alfa or pembrolizumab).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to >=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) Based on RECIST v1.1 | ORR was defined as percentage of participants with complete response (CR) or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study drug until first PD or death, whichever occurred first (up to 49 weeks) |
Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
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 | Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to >=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Mural Oncology, Inc. | +1 (781) 614-0100 | clinicaltrials@muraloncology.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2018 | Aug 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2021 | Aug 6, 2024 | SAP_001.pdf |
Not provided
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
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| Pembrolizumab | Drug | Pembrolizumab IV infusion. |
|
|
| From first documented CR or PR until first documentation of PD (up to 49 weeks) |
| Progression-free Survival (PFS) Based on RECIST v1.1 | PFS was defined as the time (in months) from the date of first dose of study drug to the date of first documentation of objective tumor progression, start of alternate therapy or death due to any cause, whichever occurred first, based on RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions. | From the first dose of study drug to date of PD, start of alternate therapy or death, whichever occurred first (up to 49 weeks) |
| Time to Progression (TTP) Based on RECIST v1.1 | TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD based on RECIST 1.1. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the baseline SOD of target lesions. | From first dose of study drug to the date of the first documentation of PD (up to 49 weeks) |
| Disease Control Rate (DCR) Based on RECIST v1.1 | DCR was defined as percentage participants with a confirmed CR, PR, or SD as assessed by an investigator based on RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). | From first dose of study drug until PD or death, whichever occurred first (up to 49 weeks) |
| Overall Survival (OS) | OS was defined as the time from the date of the first dose of study drug until the date of death due to any cause. Participants were followed for survival after the last dose of study drug. | From date of first dose of study drug up to death from any cause (up to 89 weeks) |
| Number of Participants With Drug-related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required participant's hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect. TEAE included AE that occurred or worsen after the first dose of study drug. The assessment of the relationship of study drug to TEAEs and SAEs was done by the Investigator (or designated sub-Investigator) according to their best clinical judgment. | From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks) |
| Number of Participants With Drug-related TEAEs Leading to Discontinuation of Treatment | An AE was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product. TEAE included AE that occurred or worsen after the first dose of study drug. The assessment of the relationship of study drug to AEs was done by the Investigator (or designated sub-Investigator) according to their best clinical judgment. | From first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks) |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Mural Oncology Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| Mural Oncology Investigational Site | New York | New York | 10016 | United States |
| Mural Oncology Investigational Site | New York | New York | 10029 | United States |
| Mural Oncology Investigational Site | Cleveland | Ohio | 44195 | United States |
| Mural Oncology Investigational Site | Austin | Texas | 78712 | United States |
| Death |
|
| BG001 | Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after >=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| 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 |
|
| ID | Title | Description |
|---|
| OG000 | Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to >=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
| OG001 | Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after >=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. |
|
|
| Secondary | Duration of Response (DOR) Based on RECIST v1.1 | DOR was defined as time in months from the first documentation CR or PR until the first documentation of confirmed PD as assessed by investigator based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline. Here, 'overall number of participants analyzed' signifies participants who had CR or PR. | Posted | Median | 95% Confidence Interval | months | From first documented CR or PR until first documentation of PD (up to 49 weeks) |
|
|
|
| Secondary | Progression-free Survival (PFS) Based on RECIST v1.1 | PFS was defined as the time (in months) from the date of first dose of study drug to the date of first documentation of objective tumor progression, start of alternate therapy or death due to any cause, whichever occurred first, based on RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions. | Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline. | Posted | Median | 95% Confidence Interval | months | From the first dose of study drug to date of PD, start of alternate therapy or death, whichever occurred first (up to 49 weeks) |
|
|
|
| Secondary | Time to Progression (TTP) Based on RECIST v1.1 | TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD based on RECIST 1.1. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the baseline SOD of target lesions. | Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug to the date of the first documentation of PD (up to 49 weeks) |
|
|
|
| Secondary | Disease Control Rate (DCR) Based on RECIST v1.1 | DCR was defined as percentage participants with a confirmed CR, PR, or SD as assessed by an investigator based on RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). | Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until PD or death, whichever occurred first (up to 49 weeks) |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of the first dose of study drug until the date of death due to any cause. Participants were followed for survival after the last dose of study drug. | Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline. | Posted | Median | 95% Confidence Interval | months | From date of first dose of study drug up to death from any cause (up to 89 weeks) |
|
|
|
| Secondary | Number of Participants With Drug-related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required participant's hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect. TEAE included AE that occurred or worsen after the first dose of study drug. The assessment of the relationship of study drug to TEAEs and SAEs was done by the Investigator (or designated sub-Investigator) according to their best clinical judgment. | Safety population included participants who received at least one dose of either study drug (nemvaleukin alfa or pembrolizumab). | Posted | Count of Participants | Participants | From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks) |
|
|
|
| Secondary | Number of Participants With Drug-related TEAEs Leading to Discontinuation of Treatment | An AE was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product. TEAE included AE that occurred or worsen after the first dose of study drug. The assessment of the relationship of study drug to AEs was done by the Investigator (or designated sub-Investigator) according to their best clinical judgment. | Safety population included participants who received at least one dose of either study drug (nemvaleukin alfa or pembrolizumab). | Posted | Count of Participants | Participants | From first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks) |
|
|
|
| 6 |
| 8 |
| 4 |
| 8 |
| 8 |
| 8 |
| EG001 | Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after >=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation. | 3 | 6 | 2 | 6 | 6 | 6 |
| Skin infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Lymph node pain | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| Wound secretion | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA version 24.0 | Systematic Assessment |
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| Ear discomfort | Ear and labyrinth disorders | MedDRA version 24.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Skin neoplasm bleeding | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
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| Device occlusion | Product Issues | MedDRA version 24.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
|
Not provided
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| Nemvaleukin Alfa Related SAEs |
|
| Pembrolizumab Related SAEs |
|