Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004896-38 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
Not provided
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The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S64315 (also referred as MIK665) with azacitidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S 64315 (also referred as MIK665) and azacitidine | Drug | The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) (Phase I - Dose Escalation) | Incidence of DLTs starting from the Lead-In Dose period to the end of the first cycle of treatment of S64315 in combination with azacitidine. | Day -13 to Cycle 1 Day 28 (each cycle is 28 days) |
| Number of Adverse Events (AEs) and Severe AEs (Phase I - Dose Escalation) | Incidence and severity of AEs according to NCI CTCAE v5.0 | an average of 6 months |
| Number of Serious Adverse Event (SAEs) and Fatal SAEs (Phase I - Dose Escalation) | Incidence and severity of SAEs according to NCI CTCAE v5.0 | Day -13 up to 30 calendar days after the patient's last study visit (an average of 6 months) |
| Number of Participants With Dose Interruptions (Phase I - Dose Escalation) | Through study completion, an average of 6 months | |
| Number of Participants With Dose Reductions (Phase I - Dose Escalation) | Through study completion, an average of 6 months | |
| Dose Intensity for S64315 (Phase I - Dose Escalation) | Through study completion, an average of 6 months | |
| Dose Intensity for Azacitidine (Phase I - Dose Escalation) | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Anti-leukemic Activity of S64315 in Combination With Azacitidine (Phase I - Dose Escalation) | Overall survival (OS) | Through study completion, an average of 6 months |
| Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine | Houston | Texas | 77030 | United States | ||
Not provided
| Label | URL |
|---|---|
| Find Results on Servier Clinical Trial Data website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 50 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| FG001 | 100 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| FG002 | 190 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 50 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| 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 Limiting Toxicity (DLT) (Phase I - Dose Escalation) | Incidence of DLTs starting from the Lead-In Dose period to the end of the first cycle of treatment of S64315 in combination with azacitidine. | Posted | Count of Participants | Participants | Day -13 to Cycle 1 Day 28 (each cycle is 28 days) |
|
Up to 30 days after the patients last study visit (an average of 6 months)
Not provided
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 | 50 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Department | Institut de Recherches Internationales Servier (I.R.I.S.) | +33 1 55 72 60 00 | scientificinformation@servier.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2022 | Mar 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2023 | Mar 15, 2024 | SAP_001.pdf |
Not provided
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
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|
Duration of response (DOR) |
| Through study completion, an average of 6 months |
| Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) | Best overall response (BOR) | Through study completion, an average of 6 months |
| Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) | Progression-free survival (PFS) | Through study completion, an average of 6 months |
| Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) | Disease-free survival (DFS) | Through study completion, an average of 6 months |
| Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Area Under the Curve (AUC) (Phase I - Dose Escalation) | At Cycle 1 Day 2 and Cycle 1 Day 9 (each cycle is 28 days) |
| Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Maximum Concentration (Cmax) (Phase I - Dose Escalation) | At Cycle 1 Day 2 and Cycle 1 Day 9 (each cycle is 28 days) |
| Victorian Comprehensive Cancer Centre |
| Melbourne |
| 3002 |
| Australia |
| The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services | Melbourne | 3004 | Australia |
| Institut Paoli-Calmettes | Marseille | France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| H. Universitario Valle de Hebrón Servicio de Hematología | Barcelona | 08035 | Spain |
| H. Universitario La Fe Servicio de Hematologia | Valencia | 46026 | Spain |
| Study Protocol | View IPD |
| Statistical Analysis Plan | View IPD |
| Informed Consent Form | View IPD |
| Clinical Study Report | View IPD |
| study-level clinical trial data | View IPD |
| Physician Decision |
|
| BG001 | 100 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| BG002 | 190 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 100 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| OG002 | 190 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
|
|
| Primary | Number of Adverse Events (AEs) and Severe AEs (Phase I - Dose Escalation) | Incidence and severity of AEs according to NCI CTCAE v5.0 | Posted | Number | Events | an average of 6 months |
|
|
|
| Primary | Number of Serious Adverse Event (SAEs) and Fatal SAEs (Phase I - Dose Escalation) | Incidence and severity of SAEs according to NCI CTCAE v5.0 | Posted | Number | Events | Day -13 up to 30 calendar days after the patient's last study visit (an average of 6 months) |
|
|
|
| Primary | Number of Participants With Dose Interruptions (Phase I - Dose Escalation) | Posted | Count of Participants | Participants | Through study completion, an average of 6 months |
|
|
|
| Primary | Number of Participants With Dose Reductions (Phase I - Dose Escalation) | Posted | Count of Participants | Participants | Through study completion, an average of 6 months |
|
|
|
| Primary | Dose Intensity for S64315 (Phase I - Dose Escalation) | Posted | Mean | Standard Deviation | mg/week | Through study completion, an average of 6 months |
|
|
|
| Secondary | Assess Anti-leukemic Activity of S64315 in Combination With Azacitidine (Phase I - Dose Escalation) | Overall survival (OS) | In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected. | Posted | Through study completion, an average of 6 months |
|
|
| Secondary | Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) | Duration of response (DOR) | In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected. | Posted | Through study completion, an average of 6 months |
|
|
| Secondary | Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) | Best overall response (BOR) | In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected. | Posted | Through study completion, an average of 6 months |
|
|
| Secondary | Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) | Progression-free survival (PFS) | In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected. | Posted | Through study completion, an average of 6 months |
|
|
| Secondary | Assess Anti-leukemic Activity of S64315 in Combinaison With Azacitidine (Phase I - Dose Escalation) | Disease-free survival (DFS) | In the context of the premature study discontinuation due to strategic reasons, no statistical analyses for this outcome measure was completed since data was not collected. | Posted | Through study completion, an average of 6 months |
|
|
| Secondary | Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Area Under the Curve (AUC) (Phase I - Dose Escalation) | For Cycle 1 Day 9 in the 50 mg S64315 arm, the blood sample was collected from the same site of IV infusion and therefore, no descriptive statistics were derived due to unreliable PK Data. The other cohorts had less patients analyzed due to missing patient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng.h/mL | At Cycle 1 Day 2 and Cycle 1 Day 9 (each cycle is 28 days) |
|
|
|
| Secondary | Pharmacokinetic Profile of S64315 Administered in Combination With Azacitidine in Plasma: Maximum Concentration (Cmax) (Phase I - Dose Escalation) | For Cycle 1 Day 9 in the 50 mg S64315 arm, the blood sample was collected from the same site of IV infusion and therefore, no descriptive statistics were derived due to unreliable PK Data. The other cohorts had less patients analyzed due to missing patient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At Cycle 1 Day 2 and Cycle 1 Day 9 (each cycle is 28 days) |
|
|
|
| Primary | Dose Intensity for Azacitidine (Phase I - Dose Escalation) | One participant in the 100 mg arm did not receive azacitidine and therefore was not eligible for analysis. | Posted | Mean | Standard Deviation | mg/m^2/week | Through study completion, an average of 6 months |
|
|
|
| 2 |
| 5 |
| 5 |
| 5 |
| 5 |
| 5 |
| EG001 | 100 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. | 5 | 7 | 7 | 7 | 6 | 7 |
| EG002 | 190 mg S64315 (Also Referred as MIK665) With Azacitidine | S 64315 (also referred as MIK665) and azacitidine: The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. | 2 | 5 | 4 | 5 | 5 | 5 |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Anorectal cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Sinusitis aspergillus | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Troponin I increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Troponin T increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Administration site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperleukocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Herpes simplex reactivation | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Deafness bilateral | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Cycle 1 Day 9 |
|
|
| Cycle 1 Day 9 |
|
|