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This Phase II study will recruit 40 metastatic non-small cell lung cancer patients who failed treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody, administered simultaneously or sequentially. All recruited patients will receive AB-16B5 at a dose of 12 mg/kg once weekly combined with docetaxel at a dose of 75 mg/m2 once every 3 weeks.
This is an open-label, single-arm, multi-center Phase II trial of AB-16B5 in combination with docetaxel in previously treated subjects with metastatic non-small cell lung cancer who have experienced disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody, administered simultaneously or sequentially. Approximately 40 subjects will be enrolled in this trial and receive AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 once every 3 weeks on Day 1. One cycle of treatment will consist of 21 days (3 weeks). The safety profile of the AB-16B5 and docetaxel combination will be examined during a safety lead-in period with the first 8 subjects completing one cycle of treatment. No dose escalation will be performed but a decision to de-escalate the AB-16B5 dose could be made using the modified toxicity probability interval method.
Subjects will be evaluated every 6 weeks with radiographic imaging to assess response to treatment using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for determination of the objective response rate (ORR) and progression free survival (PFS). Paired tumor biopsies (pre-treatment and on-treatment) will be collected in all subjects. Study treatment will continue until there is evidence of disease progression, treatment-related adverse events of unacceptable severity, subject request for discontinuation or Investigator determination that further treatment is not in the subject's best interest. Treatment through progression will be allowed if the Investigator considers the subject to be clinically stable. Subjects who must discontinue docetaxel due to toxicity will continue on AB-16B5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm AB-16B5 and Docetaxel | Experimental | AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 once every 3 weeks on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-16B5 | Drug | AB-16B5 is an inhibitor of the epithelial to mesenchymal transition. It is a fully humanized monoclonal antibody of IgG2 isotype against tumor-associated secreted clusterin (TA-sCLU). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate (ORR) was defined as the percent of subjects documented to have a confirmed complete response (CR) or partial response (PR) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions. | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) | Clinical benefit rate (CBR) was defined as the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
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Inclusion Criteria:
Subjects (male or non-pregnant female) must be ≥ 18 years of age on the day of signing the informed consent.
Subjects with a histologically or cytologically confirmed diagnosis of (Stage III-IV) non-small cell lung cancer (NSCLC) and with at least one measurable lesion defined by RECIST 1.1.
Subjects must have experienced a disease progression following treatment with an anti-PD1 or PD-L1 immune checkpoint antibody and a platinum-containing doublet treatment, administered simultaneously or sequentially.
Subjects with a targetable driver mutation in EGFR or ALK gene will be allowed on trial after failing all available targeted therapies and having experienced a disease progression following treatment with an anti-PD1 or PD-L1 immune checkpoint antibody and a platinum-containing doublet treatment, administered simultaneously or sequentially.
Subjects must have adequate organ and immune function
Subjects must have a tumor lesion amenable for biopsies with no contraindication for biopsy.
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Subjects must have a life expectancy of at least 3 months.
Subjects must have recovered from the toxic effects resulting from the most recent cancer treatment to Grade 1 or less. If the subjects underwent major surgery or received radiation therapy, they must have recovered from the complications and/or toxicity.
Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
Subjects (both male and female) of reproductive potential must be willing to practice highly effective methods of contraception throughout the study and for up to 90 days after the last dose of study medication. Abstinence is acceptable if this is the subject's usual lifestyle.
Female subjects are not considered of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following:
Subjects must understand and be able and willing and likely to fully comply with the study procedures, including scheduled follow-up, and restrictions.
Subjects must have given written personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, before completing any study related procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Laurin | Alethia Biotherapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Hôpital Maisonneuve-Rosemont |
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| ID | Title | Description |
|---|---|---|
| FG000 | AB-16B5 12 mg/kg & Docetaxel 75 mg/m2 | Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AB-16B5 12 mg/kg & Docetaxel 75 mg/m2 | Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first. |
| 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 | Objective Response Rate (ORR) | Objective response rate (ORR) was defined as the percent of subjects documented to have a confirmed complete response (CR) or partial response (PR) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Objective Response Rate was the Clinical Activity Evaluable (CAE) population which included all subjects who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel) and who had at least one on-study disease assessment (post-dose) or developed early progression and discontinued study treatment prior to the first planned on-study disease assessment. | Posted | Count of Participants | Participants | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
|
For up to 3 years.
All-cause mortality includes deaths that occurred during study treatment period and survival follow-up.
Treatment-emergent adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AB-16B5 12 mg/kg & Docetaxel 75 mg/m2 | Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Laurin, Vice-President, Drug Development | Alethia Biotherapeutics ULC | 514-581-8125 | julie.laurin@alethiabio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2023 | Jan 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | Docetaxel is an anticancer chemotherapy drug approved in the treatment of non-small cell lung cancer |
|
| Every 6 weeks until the date of objectively documented progression for up to 2 years. |
| Duration of Response (DOR) | Duration of response (DOR) was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. DOR was calculated only for the subjects achieving a confirmed CR or PR. As per RECIST 1.1, Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
| Duration of Clinical Benefit | Duration of clinical benefit (CB) was defined as the time from date of the first documentation of clinical benefit (either CR, PR or SD) to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. Duration of clinical benefit was calculated only for the subjects achieving a clinical benefit. As per RECIST 1.1, Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
| Duration of Stable Disease | Duration of stable disease (SD) was defined as the time from the date of the first study treatment to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. Duration of stable disease was calculated only for the subjects achieving a stable disease as their best overall response. The best overall response was defined as the best response recorded from the start of the study treatment until the end of study. As per RECIST 1.1, Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
| Progression Free Survival (PFS) | Progression-free survival (PFS) was defined as the time from the date of first study treatment to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. For subjects who remained alive without progression at the end of the study, the event date was censored at the date of last disease assessment. As per RECIST 1.1, Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
| Overall Survival (OS) | Overall survival (OS) was defined as the time from date of first study treatment to death due to any cause. For surviving subjects at the end of the study, the OS endpoint was censored at the date of last contact (or last date known to be alive). | From the start of study treatment up to the date of death or date of last contact for up to 3 years. |
| Montreal |
| Quebec |
| H1T 2M4 |
| Canada |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2X 3E4 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) | Québec | Quebec | G1V 4G5 | Canada |
| Centre Intégré de Santé et de Services Sociaux des Laurentides (Hôpital Régional de St-Jérôme) | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Death |
|
| Other |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Histological Classification of NSCLC | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Score | The ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. 0. Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
|
Subjects were treated in 21-day cycles with AB-16B5 at a dose of 12 mg/kg once weekly on Days 1, 8 and 15 combined with docetaxel at a dose of 75 mg/m2 on Day 1. Study treatment continued until there was evidence of disease progression, unacceptable toxicity, withdrawal of consent or the Investigator felt that further treatment was not in the subject's best interest, whichever occurred first. |
|
|
| Secondary | Clinical Benefit Rate (CBR) | Clinical benefit rate (CBR) was defined as the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST 1.1 where Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Clinical Benefit Rate was the Clinical Activity Evaluable (CAE) population which included all subjects who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel) and who had at least one on-study disease assessment (post-dose) or developed early progression and discontinued study treatment prior to the first planned on-study disease assessment. | Posted | Count of Participants | Participants | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
|
|
|
| Secondary | Duration of Response (DOR) | Duration of response (DOR) was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. DOR was calculated only for the subjects achieving a confirmed CR or PR. As per RECIST 1.1, Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Duration of Response was the subjects achieving a confirmed CR or PR and who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel). | Posted | Median | 95% Confidence Interval | Days | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
|
|
|
| Secondary | Duration of Clinical Benefit | Duration of clinical benefit (CB) was defined as the time from date of the first documentation of clinical benefit (either CR, PR or SD) to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. Duration of clinical benefit was calculated only for the subjects achieving a clinical benefit. As per RECIST 1.1, Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Duration of Clinical Benefit was the subjects achieving a clinical benefit (either CR, PR or SD) and who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel). | Posted | Median | 95% Confidence Interval | Days | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
|
|
|
| Secondary | Duration of Stable Disease | Duration of stable disease (SD) was defined as the time from the date of the first study treatment to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. Duration of stable disease was calculated only for the subjects achieving a stable disease as their best overall response. The best overall response was defined as the best response recorded from the start of the study treatment until the end of study. As per RECIST 1.1, Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Duration of Stable Disease was the subjects achieving a stable disease as their best overall response and who received at least one dose of each study treatment drug (AB-16B5 and Docetaxel). | Posted | Median | 95% Confidence Interval | Days | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progression-free survival (PFS) was defined as the time from the date of first study treatment to the first documentation of objective progression of disease (PD) as per RECIST 1.1 or to death due to any cause in the absence of documented PD. For subjects who remained alive without progression at the end of the study, the event date was censored at the date of last disease assessment. As per RECIST 1.1, Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, or the appearance of one or more new lesions. | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint of Progression-free Survival was the modified Intent-to-Treat (mITT) population which included subjects who received at least one dose of each study treatment (AB-16B5 and Docetaxel). | Posted | Median | 95% Confidence Interval | Days | Every 6 weeks until the date of objectively documented progression for up to 2 years. |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival (OS) was defined as the time from date of first study treatment to death due to any cause. For surviving subjects at the end of the study, the OS endpoint was censored at the date of last contact (or last date known to be alive). | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall Survival was the modified Intent-to-Treat (mITT) population which included subjects who received at least one dose of each study treatment (AB-16B5 and Docetaxel). | Posted | Median | 95% Confidence Interval | Days | From the start of study treatment up to the date of death or date of last contact for up to 3 years. |
|
|
|
| 23 |
| 35 |
| 23 |
| 35 |
| 35 |
| 35 |
| Diverticulitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Diverticulitis intestinal perforated | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Groin infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Vascular stent thrombosis | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
|
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |