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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1184-2041 | Other Identifier | WHO | |
| 2016-001681-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.
The drug being tested in this study is called ixazomib. This study will look at the long term safety profile of ixazomib in participants who have previously received and tolerated ixazomib in a Takeda-sponsored clinical study, and in the investigator's opinion and approved by the Takeda medical monitor, may benefit from continued ixazomib therapy.
The study will enroll approximately 250 patients.
All participants will receive ixazomib as a single agent or in combination with other study drugs at same dose and schedule that they were receiving in the parent study until they experience disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until ixazomib is available to the participant is transitioned to ixazomib/other therapy through commercial channels, including reimbursement for the participant's indication, whichever is sooner.
This multicenter, rollover study will be conducted worldwide. The overall time to participate in this study is up to 7 years. Participants will make multiple visits to the clinic, and a final visit after 30 days of last dose of study drug for a safety assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixazomib Monotherapy | Experimental | Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner. |
|
| Ixazomib Combination Therapy | Experimental | Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib | Drug | Ixazomib Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an AE in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. | Up to 7 years |
| Number of Participants With ≥ Grade 3 AEs | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE. | Up to 7 years |
| Number of Participants With ≥ Grade 2 Peripheral Neuropathy | Severity grade was evaluated based on CTCAE version 5.0. Grade 2: moderate symptoms; limiting instrumental activities of daily living. Grade 3: severe or medically significant; limiting self-care activities of daily living. Grade 4: life threatening consequences; urgent intervention indicated. |
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Inclusion Criteria:
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of treatment in the parent study or as agreed by the Takeda clinician/designee.
Previously treated with ixazomib, background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Participants will be eligible to enter the rollover study when:
Agree to continue to practice contraceptive methods as outlined in the parent study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Appalachian Regional Healthcare |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants who had previously received and tolerated treatment in ixazomib parent studies (C16003 [NCT00932698], C16005 [NCT01217957], C16006 [NCT01335685],C16007 [NCT01318902],C16008 [NCT01383928],C16010 Global [NCT01564537],C16011 [NCT01659658],C16013 [NCT01645930],C16014 Global [NCT01850524] and Korean Continuation,C16017 [NCT01939899],C16020 [NCT02046070],C16029 [NCT03170882], or C16047 [NCT03439293]), and in investigator's opinion could benefit from continued therapy were enrolled.
Participants took part in the study at various investigative sites globally from 16 December 2016 to 03 July 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixazomib Monotherapy | Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner. |
| FG001 | Ixazomib Combination Therapy | Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixazomib Monotherapy | Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an AE in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. | Safety Population included all enrolled participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | Up to 7 years |
Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
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 | Ixazomib Monotherapy | Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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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 | Jun 3, 2021 | Feb 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2023 | Feb 25, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C548400 | ixazomib |
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Not provided
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Not provided
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| Up to 7 years |
| Number of Participants With New Primary Malignancies | Up to 7 years |
| Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. | Up to 7 years |
| Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. Any AE interpreted by the investigator as a clinically significant event was reported. | Up to 7 years |
| Hazard |
| Kentucky |
| 41701 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| UZ Leuven | Leuven | 3000 | Belgium |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 1X5 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| 1st Affiliated Hospital of Zhejiang University | Hangzhou | 310003 | China |
| Shanghai Chang Zheng Hospital | Shanghai | 200003 | China |
| Laiko General Hospital of Athens | Athens | Attica | 115 27 | Greece |
| University of Athens Medical School - Regional General Hospital Alexandra | Athens | 11528 | Greece |
| Tokyo Metropolitan Komagome Hospital | Bunkyo-Ku | Tokyo | 113-8677 | Japan |
| Japanese Red Cross Medical Center | Shibuya-Ku | Tokyo | 150-8935 | Japan |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów | Silesian Voivodeship | 41-500 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | 93-510 | Poland |
| Centrum Onkologii Ziemi Lubelskiej | Lublin | 20-090 | Poland |
| MTZ Clinical Research Sp z o o | Warsaw | 02-106 | Poland |
| National University Hospital | Singapore | 119082 | Singapore |
| Asan Medical Center - PPDS | Seoul | 5505 | South Korea |
| Hospital Universitario de Donostia | Donostia / San Sebastian | 20014 | Spain |
| Complejo Asistencial Universitario de Salamanca H. Clinico | Salamanca | 37007 | Spain |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | Södermanland County | Sweden |
| Skanes Universitetssjukhus Lund | Lund | 22185 | Sweden |
| Karolinska Universitetssjukhuset Solna | Stockholm | SE-17176 | Sweden |
| Adverse Event |
|
| Progressive Disease |
|
| Clinical Deterioration |
|
| Death |
|
| Reason Not Specified |
|
| BG001 | Ixazomib Combination Therapy | Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Ixazomib Monotherapy | Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner. |
| OG001 | Ixazomib Combination Therapy | Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner. |
|
|
| Primary | Number of Participants With ≥ Grade 3 AEs | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE. | Safety Population included all enrolled participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | Up to 7 years |
|
|
|
| Primary | Number of Participants With ≥ Grade 2 Peripheral Neuropathy | Severity grade was evaluated based on CTCAE version 5.0. Grade 2: moderate symptoms; limiting instrumental activities of daily living. Grade 3: severe or medically significant; limiting self-care activities of daily living. Grade 4: life threatening consequences; urgent intervention indicated. | Safety Population included all enrolled participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | Up to 7 years |
|
|
|
| Primary | Number of Participants With New Primary Malignancies | Safety Population included all enrolled participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | Up to 7 years |
|
|
|
| Primary | Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. | Safety Population included all enrolled participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | Up to 7 years |
|
|
|
| Primary | Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. Any AE interpreted by the investigator as a clinically significant event was reported. | Safety Population included all enrolled participants who received at least 1 dose of ixazomib. | Posted | Count of Participants | Participants | Up to 7 years |
|
|
|
| 1 |
| 23 |
| 12 |
| 23 |
| 9 |
| 23 |
| EG001 | Ixazomib Combination Therapy | Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner. | 0 | 9 | 4 | 9 | 6 | 9 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Bladder injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Sebaceous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Tuberculous pleurisy | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| 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 |
| D008206 | Lymphatic Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |