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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004354-21 | EudraCT Number |
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This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone | Experimental |
| |
| Arm B: Bortezomib plus Pomalidomide and Dexamethasone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belantamab mafodotin | Drug | Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter (cm) in short axis. | Up to approximately 174 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause. | Up to approximately 473 weeks |
| Duration of Response (DoR) |
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Inclusion Criteria:
Capable of giving signed informed consent.
Male or female, 18 years or older.
Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
Must have at least 1 aspect of measurable disease defined as one of the following;
Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
Adequate organ system functions as mentioned in the protocol.
Male and female participants agree to abide by protocol-defined contraceptive requirements.
Exclusion Criteria:
Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
Prior allogeneic SCT.
Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
Plasmapheresis within 7 days prior to the first dose of study drug.
Received prior treatment with or intolerant to pomalidomide.
Received prior Beta cell maturation antigen (BCMA) targeted therapy.
Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly).
Evidence of cardiovascular risk including any of the following;
Any major surgery within the last 4 weeks.
Previous or concurrent invasive malignancy other than multiple myeloma, except:
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
Evidence of active mucosal or internal bleeding.
Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
Active infection requiring treatment.
Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy.
Active or history of venous and arterial thromboembolism within the past 3 months.
Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
Current corneal disease except for mild punctate keratopathy.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Pregnant or lactating female.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | 85712 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41193117 | Derived | Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Wilkes J, McNamara S, Phillips-Jones A, Morris K, Pompilus F, Purser M, Sule N, Kremer B, Loubert A, Bunod L, M'Hari M, Zhou XL, Fulci G, Mateos MV, Trudel S; DREAMM-8 investigators. Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Nov;12(11):e876-e886. doi: 10.1016/S2352-3026(25)00256-X. | |
| 40958065 |
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GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belantamab Mafodotin+Pomalidomide+Dexamethasone | Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
| 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 | Sep 28, 2023 | Jan 27, 2025 |
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| Pomalidomide | Drug | Immunomodulatory drug (IMiD) will be administered. |
|
| Dexamethasone | Drug | Synthetic glucocorticoid with anti-tumor activity will be administered. |
|
| Bortezomib | Drug | Proteasome Inhibitor will be administered. |
|
Duration of Response (DoR) defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria.
| Up to approximately 473 weeks |
| Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing at 10^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG. | Up to approximately 473 weeks |
| Overall Response Rate (ORR) | ORR will be defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Up to approximately 473 weeks |
| Complete Response Rate (CRR) | Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria. | Up to approximately 473 weeks |
| Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better | VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Up to approximately 473 weeks |
| Time to Best Response (TTBR) | TTBR defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG. | Up to approximately 473 weeks |
| Time to Response (TTR) | TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG. | Up to approximately 473 weeks |
| Time to Progression (TTP) | TTP defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD. | Up to approximately 473 weeks |
| Progression-Free Survival 2 (PFS2) | PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier. | Up to approximately 473 weeks |
| Number of Participants With Adverse Events (AEs) | Up to approximately 473 weeks |
| Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples will be collected for the analysis of hematology parameters. | Up to approximately 473 weeks |
| Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples will be collected for the analysis of clinical chemistry parameters. | Up to approximately 473 weeks |
| Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Up to approximately 473 weeks |
| Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Up to approximately 473 weeks |
| Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Up to approximately 473 weeks |
| Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 473 weeks |
| Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 473 weeks |
| Maximum Concentration (Cmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 473 weeks |
| Time of Cmax (Tmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 473 weeks |
| Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 473 weeks |
| Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 473 weeks |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers. | Up to approximately 473 weeks |
| Titers of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further characterized for antibody titers. | Up to approximately 473 weeks |
| Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) | The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. | Up to approximately 473 weeks |
| Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) | The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represents better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represents significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Up to approximately 473 weeks |
| Change From Baseline in Quality of Life Questionnaire 20-item Multiple Myeloma Module (QLQMY20) | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning. | Up to approximately 473 weeks |
| Change From Baseline in HRQoL as Measured by EORTC IL52 | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning. | Up to approximately 473 weeks |
| Fort Myers |
| Florida |
| 33901 |
| United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64132 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Garran | Australian Capital Territory | 2605 | Australia |
| GSK Investigational Site | Darlinghurst | New South Wales | 2010 | Australia |
| GSK Investigational Site | Gosford NSW | New South Wales | 2250 | Australia |
| GSK Investigational Site | Port Macquarie | New South Wales | 2444 | Australia |
| GSK Investigational Site | Benowa | Queensland | 4217 | Australia |
| GSK Investigational Site | South Brisbane | Queensland | 4101 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Fitzroy | Victoria | 3065 | Australia |
| GSK Investigational Site | Heidelberg | Victoria | 3084 | Australia |
| GSK Investigational Site | Malvern | Victoria | 3144 | Australia |
| GSK Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| GSK Investigational Site | Curitiba | 01308-050 | Brazil |
| GSK Investigational Site | Joinville | 89201-260 | Brazil |
| GSK Investigational Site | São Paulo | 04537-081 | Brazil |
| GSK Investigational Site | Beijing | 100191 | China |
| GSK Investigational Site | Beijing | China |
| GSK Investigational Site | Changchun | 130012 | China |
| GSK Investigational Site | Changsha | 410013 | China |
| GSK Investigational Site | Guangzhou | 510060 | China |
| GSK Investigational Site | Hangzhou | 310003 | China |
| GSK Investigational Site | Jiangsu | 221004 | China |
| GSK Investigational Site | Nanchang | 330006 | China |
| GSK Investigational Site | Shenyang | 110004 | China |
| GSK Investigational Site | Shenzhen | 518029 | China |
| GSK Investigational Site | Tianjin | 300020 | China |
| GSK Investigational Site | Wuhan | 430022 | China |
| GSK Investigational Site | Brno | 62500 | Czechia |
| GSK Investigational Site | Hradec Králové | 50333 | Czechia |
| GSK Investigational Site | Prague | 12808 | Czechia |
| GSK Investigational Site | Marseille | 13273 | France |
| GSK Investigational Site | Toulouse | 31059 | France |
| GSK Investigational Site | Vanduvre-lEs-Nancy | 54511 | France |
| GSK Investigational Site | Mainz | 55131 | Germany |
| GSK Investigational Site | Tübingen | 72076 | Germany |
| GSK Investigational Site | Würzburg | 97080 | Germany |
| GSK Investigational Site | Athens | 10676 | Greece |
| GSK Investigational Site | Athens | 115 25 | Greece |
| GSK Investigational Site | Athens | 115 28 | Greece |
| GSK Investigational Site | Ioannina | 45 500 | Greece |
| GSK Investigational Site | Thessaloniki | 57010 | Greece |
| GSK Investigational Site | Haifa | 3109601 | Israel |
| GSK Investigational Site | Jerusalem | 91031 | Israel |
| GSK Investigational Site | Kfar Saba | 4428164 | Israel |
| GSK Investigational Site | Nahariya | 2633737 | Israel |
| GSK Investigational Site | Petah Tikva | 4941492 | Israel |
| GSK Investigational Site | Tel Aviv | 6423906 | Israel |
| GSK Investigational Site | Bologna | 40138 | Italy |
| GSK Investigational Site | Milan | 20122 | Italy |
| GSK Investigational Site | Pavia | 27100 | Italy |
| GSK Investigational Site | Roma | 00161 | Italy |
| GSK Investigational Site | Aichi | 467-8602 | Japan |
| GSK Investigational Site | Chiba | 277-8567 | Japan |
| GSK Investigational Site | Chiba | 296-8602 | Japan |
| GSK Investigational Site | Ehime | 790-8524 | Japan |
| GSK Investigational Site | Fukushima | 960-1295 | Japan |
| GSK Investigational Site | Gunma | 371-8511 | Japan |
| GSK Investigational Site | Gunma | 377-0280 | Japan |
| GSK Investigational Site | Hokkaido | 060-8648 | Japan |
| GSK Investigational Site | Numakunai | 028-3695 | Japan |
| GSK Investigational Site | Okayama | 701-1192 | Japan |
| GSK Investigational Site | Osaka | 565-0871 | Japan |
| GSK Investigational Site | Tottori | 683-8504 | Japan |
| GSK Investigational Site | Yamagata | 990-9585 | Japan |
| GSK Investigational Site | Auckland | 1023 | New Zealand |
| GSK Investigational Site | Auckland | 2025 | New Zealand |
| GSK Investigational Site | Dunedin | 9016 | New Zealand |
| GSK Investigational Site | Hamilton | 3204 | New Zealand |
| GSK Investigational Site | Takapuna Auckland | 622 | New Zealand |
| GSK Investigational Site | Tauranga | 3143 | New Zealand |
| GSK Investigational Site | Bydgoszcz | 85-168 | Poland |
| GSK Investigational Site | Gdansk | 80-214 | Poland |
| GSK Investigational Site | Krakow | 31-501 | Poland |
| GSK Investigational Site | Lodz | 93-513 | Poland |
| GSK Investigational Site | Wroclaw | 50-367 | Poland |
| GSK Investigational Site | Moscow | 125101 | Russia |
| GSK Investigational Site | Moscow | 125284 | Russia |
| GSK Investigational Site | Novosibirsk | 630087 | Russia |
| GSK Investigational Site | Saint Petersburg | 191024 | Russia |
| GSK Investigational Site | Saint Petersburg | 194291 | Russia |
| GSK Investigational Site | Saint Petersburg | 197341 | Russia |
| GSK Investigational Site | Samara | 443099 | Russia |
| GSK Investigational Site | Sochi | 354057 | Russia |
| GSK Investigational Site | Gyeonggi-do | 10408 | South Korea |
| GSK Investigational Site | Hwasun | 58128 | South Korea |
| GSK Investigational Site | Inchon | 21565 | South Korea |
| GSK Investigational Site | Seoul | 03080 | South Korea |
| GSK Investigational Site | Seoul | 03722 | South Korea |
| GSK Investigational Site | Seoul | 06351 | South Korea |
| GSK Investigational Site | Seoul | 06591 | South Korea |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Barcelona | 8035 | Spain |
| GSK Investigational Site | Gijón | 33204 | Spain |
| GSK Investigational Site | L'Hospitalet de Llobrega | 08908 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28027 | Spain |
| GSK Investigational Site | MOstoles Madrid | 28933 | Spain |
| GSK Investigational Site | Murcia | 30008 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07120 | Spain |
| GSK Investigational Site | PamplonaNavarra | 31008 | Spain |
| GSK Investigational Site | Pozuelo de AlarcOn Madr | 28223 | Spain |
| GSK Investigational Site | Salamanca | 37007 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Valencia | 46026 | Spain |
| GSK Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| GSK Investigational Site | Ankara | 6340 | Turkey (Türkiye) |
| GSK Investigational Site | Ankara | 6560 | Turkey (Türkiye) |
| GSK Investigational Site | Izmir | 35100 | Turkey (Türkiye) |
| GSK Investigational Site | Izmir | 35330 | Turkey (Türkiye) |
| GSK Investigational Site | Kocaeli | 41400 | Turkey (Türkiye) |
| GSK Investigational Site | Mersin | 33343 | Turkey (Türkiye) |
| GSK Investigational Site | Samsun | 55139 | Turkey (Türkiye) |
| GSK Investigational Site | London | W12 0HS | United Kingdom |
| GSK Investigational Site | Plymouth | PL6 8D8 | United Kingdom |
| GSK Investigational Site | Southampton | SO16 6YD | United Kingdom |
| GSK Investigational Site | Stoke-on-Trent | ST4 6QG | United Kingdom |
| GSK Investigational Site | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Hanafin P, Ho YL, Papathanasiou T, Fulci G, Sule N, Kremer BE, Ferron-Brady G. Belantamab Mafodotin with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: A Comprehensive Exposure-Response Analysis of the DREAMM-8 Study. Target Oncol. 2025 Sep;20(5):833-845. doi: 10.1007/s11523-025-01174-0. Epub 2025 Sep 16. |
| 40763276 | Derived | Mateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev V, Pitombeira de Lacerda M, Aparecida-Martinez G, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria V, Dimopoulos MA. Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials. Blood Adv. 2025 Nov 25;9(22):5708-5719. doi: 10.1182/bloodadvances.2025016949. |
| 38828951 | Derived | Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Morris K, Pompilus F, Phillips-Jones A, Zhou XL, Fulci G, Sule N, Kremer BE, Opalinska J, Mateos MV, Trudel S; DREAMM-8 Investigators. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2. |
| FG001 | Pomalidomide+Bortezomib+Dexamethasone | Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter^2(m^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
|
| Safety Population | All randomized participants who received at least 1 dose of study intervention (any component). |
|
| COMPLETED | Note: Participants who died following randomization whilst on study, were considered to have completed the study. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Belantamab Mafodotin+Pomalidomide+Dexamethasone | Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
| BG001 | Pomalidomide+Bortezomib+Dexamethasone | Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter^2(m^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race categories (Asian, native Hawaiian OR other pacific islander, and mixed race where 0\ | Count of Participants | Participants |
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| 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 | Progression-Free Survival (PFS) | PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter (cm) in short axis. | Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 174 weeks |
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| Secondary | Overall Survival (OS) | Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | Duration of Response (DoR) defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing at 10^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR will be defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) | Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better | VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Best Response (TTBR) | TTBR defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival 2 (PFS2) | PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples will be collected for the analysis of hematology parameters. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples will be collected for the analysis of clinical chemistry parameters. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time of Cmax (Tmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Titers of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further characterized for antibody titers. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) | The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) | The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represents better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represents significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quality of Life Questionnaire 20-item Multiple Myeloma Module (QLQMY20) | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HRQoL as Measured by EORTC IL52 | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning. | Not Posted | Oct 2030 | Up to approximately 473 weeks | Participants |
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention [any component]).
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 | Belantamab Mafodotin+Pomalidomide+Dexamethasone | Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. | 48 | 155 | 95 | 150 | 148 | 150 |
| EG001 | Pomalidomide+Bortezomib+Dexamethasone | Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter^2(m^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. | 54 | 147 | 65 | 145 | 130 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Vestibular disorder | Ear and labyrinth disorders | MedDRA v26.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA v26.1 | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA v26.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Volvulus | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Death | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Device related thrombosis | General disorders | MedDRA v26.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA v26.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA v26.1 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA v26.1 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA v26.1 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Candida sepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Encephalitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Gastroenteritis rotavirus | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Haemophilus infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Klebsiella infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Lower respiratory tract infection viral | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Meningoencephalitis bacterial | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Meningoencephalitis herpetic | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Parainfluenzae virus infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Parvovirus B19 infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia pneumococcal | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pseudomembranous colitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pseudomonas infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Rhinovirus infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Streptococcal sepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Varicella | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Visceral leishmaniasis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
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| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA v26.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
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| Intervertebral disc space narrowing | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
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| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
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| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
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| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
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| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
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| Gastrointestinal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
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| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Corneal epithelial microcysts | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Corneal opacity | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Keratopathy | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2024 | Jan 27, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000631691 | belantamab mafodotin |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Others |
|