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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503348-15-00 | EU Trial (CTIS) Number | ||
| jRCT2031230576 | Registry Identifier | Japan Registry of Clinical Trials |
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Genmab discontinued GEN3017 program following a strategic re-evaluation of Genmab's portfolio.
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The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas.
GEN3017 will be administered via subcutaneous injections.
All participants will receive active drug; no one will be given placebo.
This multicenter trial will be conducted in 2 parts: Dose Escalation (phase 1) and Expansion (phase 2a).
The Dose Escalation Part (phase 1) of the trial will evaluate dose-limiting toxicities (DLTs) to determine the recommended phase 2 dose (RP2D), and if reached, the maximum tolerated dose (MTD) for R/R CD30+ classical Hodgkin lymphoma (cHL) and R/R CD30+ T-cell lymphoma (TCL), respectively.
The Expansion Part (phase 2a) will evaluate the anti-tumor activity of GEN3017 at the RP2D and selected dosage(s) will be assessed together with safety, immunogenicity, pharmacokinetics, and pharmacodynamics in R/R CD30+ cHL participants (including adults; and adolescent and young adults) and in participants with selected R/R CD30+ TCL subtypes (adults only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R/R CD30+ cHL Cohort | Experimental |
| |
| R/R CD30+ TCL Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEN3017 | Biological | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | A DLT was defined as any of the following toxicities except those that were clearly due to the underlying disease or extraneous cause: all Grade 5 toxicities, hematological toxicities (Grade 4 neutropenia, Grade 3 and Grade 4 febrile neutropenia lasting >2 days, Grade 4 thrombocytopenia of any duration with clinically significant bleeding or ≥ Grade 3 thrombocytopenia requiring platelet transfusion, Grade 4 anemia), non-hematological toxicities (Grade 4 cytokine release syndrome [CRS] per American Society for Transplantation and Cellular Therapy [ASTCT] criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, Grade 4 immune effector cell-associated neurotoxicity syndrome [ICANS] according to ASTCT criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, tumor lysis syndrome [TLS] Grade 4 or Grade 3 unresolved within 5 days, any ≥ Grade 3 [severe or life-threatening] non-hematological toxicities [with exceptions]). | 21 days |
| Dose Escalation Part: Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | Up to approximately 1 year 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Day 1 and Day 8 |
| Dose Escalation Part: Time to Reach Cmax (Tmax) of GEN3017 |
Not provided
Key Inclusion Criteria:
Dose Escalation Part:
Must be at least 18 years of age. For participants in the R/R cHL Cohort in the United States (US) and Australia, must be at least 16 years of age.
Histologically confirmed R/R cHL or R/R TCL.
Participants must have at least 1 measurable lesion by fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT)- or magnetic resonance imaging (MRI)-defined anatomical tumor sites and a CT scan (or MRI) with involvement of ≥1 measurable nodal lesion and/or ≥1 measurable extranodal lesion.
Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 for participants 18 years of age and above. For participants ≥16 and <18 years of age (US and Australia only), Karnofsky score of >60% per Karnofsky performance scale.
Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN3017.
R/R cHL Cohort:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Official | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Helford Clinical Research Hospital | Duarte | California | 91010 | United States | ||
| Washington University School of Medicine |
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| Label | URL |
|---|---|
| Results Summary in Plain Language | View source |
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This trial was conducted in participants with classical Hodgkin lymphoma and T-cell lymphoma. This trial was planned to be conducted in 2 parts: dose escalation and expansion; however, it was terminated during dose escalation and did not proceed to expansion.
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| ID | Title | Description |
|---|---|---|
| FG000 | GEN3017 Medium Priming Dose + Low Full Dose | Participants received GEN3017 at a medium priming dose and a low full dose. |
| FG001 | GEN3017 High Priming Dose + High Full Dose | Participants received GEN3017 at a high priming dose and a high full dose. |
| FG002 | GEN3017 Low Priming Dose + High Full Dose | Participants received GEN3017 at a low priming dose and a high full dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Measured in the Full Analysis Set (FAS), which included participants enrolled and treated with at least 1 dose of GEN3017.
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| ID | Title | Description |
|---|---|---|
| BG000 | Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose | Participants received GEN3017 at a medium priming dose and a low full dose. |
| BG001 | Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose |
| 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 | Dose Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | A DLT was defined as any of the following toxicities except those that were clearly due to the underlying disease or extraneous cause: all Grade 5 toxicities, hematological toxicities (Grade 4 neutropenia, Grade 3 and Grade 4 febrile neutropenia lasting >2 days, Grade 4 thrombocytopenia of any duration with clinically significant bleeding or ≥ Grade 3 thrombocytopenia requiring platelet transfusion, Grade 4 anemia), non-hematological toxicities (Grade 4 cytokine release syndrome [CRS] per American Society for Transplantation and Cellular Therapy [ASTCT] criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, Grade 4 immune effector cell-associated neurotoxicity syndrome [ICANS] according to ASTCT criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, tumor lysis syndrome [TLS] Grade 4 or Grade 3 unresolved within 5 days, any ≥ Grade 3 [severe or life-threatening] non-hematological toxicities [with exceptions]). | Measured in the Dose-Determining Set, which included all participants from the Safety Set who met the minimum exposure criteria and had either completed the DLT observation period or had experienced a DLT during the specified time period. | Posted | Count of Participants | Participants | 21 days |
Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
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 | Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose | Participants received GEN3017 at a medium priming dose and a low full dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | 27.1 | Systematic Assessment |
Early termination meant only a small number of participants were analyzed and data were not collected for the dose expansion part.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CLINICAL TRIAL INFORMATION | Genmab | +45 7020 2728 | clinicaltrials@genmab.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 18, 2023 | May 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
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Venous blood samples were collected for analyzing concentrations of GEN3017.
| Day 1 and Day 8 |
| Dose Escalation Part: Pre-dose (Trough) Concentration (Ctrough) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Day 1 and Day 8 |
| Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Day 1 and Day 8 |
| Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Day 1 and Day 8 |
| Dose Escalation Part: Elimination Half-life (T1/2) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Day 1 and Day 8 |
| Dose Escalation Part: Total Body Clearance (CL) of Drug From Plasma of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Day 1 and Day 8 |
| Dose Escalation Part: Volume of Distribution (Vd) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Day 1 and Day 8 |
| Dose Escalation Part: Number of Participants With Anti-drug Antibodies (ADAs) to GEN3017 | Venous blood samples were drawn for analysis of ADAs in serum samples. | Up to approximately 1 year 2 months |
| Dose Escalation Part: Objective Response Rate (ORR) | ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) based on the Lugano criteria as assessed by investigator. All other categories, including not evaluable, were considered non-response. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Data are presented for the number of participants with ORR. | Up to approximately 1 year 2 months |
| Dose Escalation Part: Duration of Response (DOR) | DOR was defined as the time from the first documentation of response (CR or PR) to the date of progressive disease or death, whichever occurred earlier based on the Lugano criteria as assessed by investigator. | Up to approximately 1 year 2 months |
| Dose Escalation Part: Time to Response (TTR) | TTR was defined as the time from Day 1 to first documentation of objective response (CR or PR) in participants achieving PR or CR based on the Lugano criteria as assessed by investigator. | Up to approximately 1 year 2 months |
| St Louis |
| Missouri |
| 63110 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia |
Participants received GEN3017 at a high priming dose and a high full dose.
| BG002 | T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose | Participants received GEN3017 at a medium priming dose and a low full dose. |
| BG003 | T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose | Participants received GEN3017 at a low priming dose and a high full dose. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | Dose Escalation Part: Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | Measured in the Safety Set, which included participants enrolled and treated with at least 1 dose of GEN3017. | Posted | Count of Participants | Participants | Up to approximately 1 year 2 months |
|
|
|
| Secondary | Dose Escalation Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Time to Reach Cmax (Tmax) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Measured in the PK Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Pre-dose (Trough) Concentration (Ctrough) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected. | Posted | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected. | Posted | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | Measured in the PK Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ug/mL | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Elimination Half-life (T1/2) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected. | Posted | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Total Body Clearance (CL) of Drug From Plasma of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected. | Posted | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Volume of Distribution (Vd) of GEN3017 | Venous blood samples were collected for analyzing concentrations of GEN3017. | While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected. | Posted | Day 1 and Day 8 |
|
|
|
| Secondary | Dose Escalation Part: Number of Participants With Anti-drug Antibodies (ADAs) to GEN3017 | Venous blood samples were drawn for analysis of ADAs in serum samples. | Measured in the Immunogenicity Analysis Set, which included all participants who received at least 1 dose of GEN3017 and had a baseline and at least 1 evaluable on-treatment ADA sample. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only. | Posted | Count of Participants | Participants | Up to approximately 1 year 2 months |
|
|
|
| Secondary | Dose Escalation Part: Objective Response Rate (ORR) | ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) based on the Lugano criteria as assessed by investigator. All other categories, including not evaluable, were considered non-response. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Data are presented for the number of participants with ORR. | Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only. | Posted | Count of Participants | Participants | Up to approximately 1 year 2 months |
|
|
|
| Secondary | Dose Escalation Part: Duration of Response (DOR) | DOR was defined as the time from the first documentation of response (CR or PR) to the date of progressive disease or death, whichever occurred earlier based on the Lugano criteria as assessed by investigator. | Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017, in participants who achieved a response. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only. | Posted | Median | 95% Confidence Interval | months | Up to approximately 1 year 2 months |
|
|
|
| Secondary | Dose Escalation Part: Time to Response (TTR) | TTR was defined as the time from Day 1 to first documentation of objective response (CR or PR) in participants achieving PR or CR based on the Lugano criteria as assessed by investigator. | Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017, in participants who achieved a response. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only. | Posted | Mean | Standard Deviation | months | Up to approximately 1 year 2 months |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose | Participants received GEN3017 at a high priming dose and a high full dose. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG002 | T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose | Participants received GEN3017 at a medium priming dose and a low full dose. | 1 | 2 | 2 | 2 | 2 | 2 |
| EG003 | T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose | Participants received GEN3017 at a low priming dose and a high full dose. | 2 | 3 | 2 | 3 | 3 | 3 |
| Pyrexia | General disorders | 27.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | 27.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | 27.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 27.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
|
| Amylase increased | Investigations | 27.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | 27.1 | Systematic Assessment |
|
| Superficial vein thrombosis | Vascular disorders | 27.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | 27.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
|
| Fatigue | General disorders | 27.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 27.1 | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | 27.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | 27.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 27.1 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | 27.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
|
| Strongyloides test positive | Investigations | 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 27.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | 27.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | 27.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 27.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 27.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 27.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | 27.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | 27.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | 27.1 | Systematic Assessment |
|
Not provided
Not provided
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Day 8 |
|
| Day 8 |
|
| Day 8 |
|