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| ID | Type | Description | Link |
|---|---|---|---|
| 173791 | Registry Identifier | JAPIC CTI |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | All participants will receive DS-8201a by intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-8201a | Drug | DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported. | Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days) |
| Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed. | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
| Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) of MAAA-1181 After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Maximum serum concentration (Cmax) of MAAA-1181 was assessed. | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
| Pharmacokinetic Parameters Area Under the Concentration-Time Curve After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody were assessed. | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan | ||
| National Cancer Center Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36164935 | Derived | Shimomura A, Takano T, Takahashi S, Sagara Y, Watanabe J, Tokunaga E, Shinkai T, Kamio T, Kikumori K, Kamiyama E, Fujisaki Y, Saotome D, Yamashita T. Effect of Trastuzumab Deruxtecan on QT/QTc Interval and Pharmacokinetics in HER2-Positive or HER2-Low Metastatic/Unresectable Breast Cancer. Clin Pharmacol Ther. 2023 Jan;113(1):160-169. doi: 10.1002/cpt.2757. Epub 2022 Oct 18. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
The 6.4 mg/kg DS-8201a dose was chosen for this study based on the efficacy, safety, and pharmacokinetic profiles established in an earlier Phase 1 trial.
A total of 51 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at 7 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | DS-8201a | Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DS-8201a | Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle. |
| 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 | Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported. | QTc and QTcF were assessed in the Cardiac Analysis Set. | Posted | Count of Participants | Participants | Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days) |
|
|
Adverse event data were collected from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 38 months post-dose.
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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 | DS-8201a | Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
Not provided
| 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 | Jul 3, 2020 | May 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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| Pharmacokinetic Parameters Area Under the Concentration-Time Curve of MAAA-1181 After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) were assessed. | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
| Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 12 months post-dose |
| Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 38 months post-dose |
| Treatment-Emergent Adverse Events of Any Grade by System Organ Classes and Preferred Term Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to approximately 12 months post-dose |
| Chuo Ku |
| Tokyo |
| 104-0045 |
| Japan |
| The Cancer Institute Hospital of Japanese Foundation For Cancer Research | Koto-Ku | Tokyo | 135-8550 | Japan |
| Toranomon Hospital | Minato-Ku | Tokyo | 105-8470 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Social Medical Corporation Hakuaikai Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| Withdrawal by Subject |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ug/mL | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
|
|
|
| Primary | Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) of MAAA-1181 After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Maximum serum concentration (Cmax) of MAAA-1181 was assessed. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
|
|
|
| Primary | Pharmacokinetic Parameters Area Under the Concentration-Time Curve After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody were assessed. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ug*d/mL | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
|
|
|
| Primary | Pharmacokinetic Parameters Area Under the Concentration-Time Curve of MAAA-1181 After Cycle 1 and Cycle 3 Treatments With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) were assessed. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng*d/mL | Cycles 1 and 3: Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4: 24 hours, 72 hours; Days 8 and 15; Cycle 2: Day 1 BI, EOI; Cycles 4, 6, and 8: Day 1 BI and EOI (each cycle is 21 days) |
|
|
|
| Secondary | Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. | Response was assessed in the Efficacy Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 12 months post-dose |
|
|
|
| Secondary | Objective Response Rate Based on The Investigator's Assessment (Unconfirmed) Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Objective response rate (ORR) was defined as unconfirmed complete response (CR) and partial response (PR) as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. | Response was assessed in the Efficacy Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 38 months post-dose |
|
|
|
| Secondary | Treatment-Emergent Adverse Events of Any Grade by System Organ Classes and Preferred Term Following DS-8201a Treatment in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer | Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug. | Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to approximately 12 months post-dose |
|
|
|
| 0 |
| 51 |
| 9 |
| 51 |
| 51 |
| 51 |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Ginsivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Angular cheilitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Dacryocystitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Vagus nerve disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Visual perseveration | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Withdrawal syndrome | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Bite | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
Not provided
Not provided
|
| Total Anti-HER2 antibody: Cycle 1 |
|
|
| Total Anti-HER2 antibody: Cycle 3 |
|
|
|
|
| AUCtau, DS-8201: Cycle 1 |
|
|
| AUCtau, DS-8201: Cycle 3 |
|
|
| AUCtau, Total Anti-HER2 antibody: Cycle 1 |
|
|
| AUCtau, Total Anti-HER2 antibody: Cycle 3 |
|
|
|
| AUCtau, MAAA-1181a: Cycle 3 |
|
|
| Title | Measurements |
|---|---|
|
| Vomiting |
|
| Constipation |
|
| Stomatitis |
|
| Diarrhoea |
|
| Investigations |
|
| Neutrophil count decreased |
|
| White blood cell count decreased |
|
| Platelet count decreased |
|
| Lymphocyte count decreased |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Blood and Lymphatic System Disorders |
|
| Anaemia |
|
| Skin and Subcutaneous Tissue Disorders |
|
| Alopecia |
|
| General Disorders and Administration Site Conditions |
|
| Fatigue |
|
| Infections and Infestations |
|
| Nasopharyngitis |
|
| Metabolism and Nutrition Disorders |
|
| Decreased appetite |
|
| Nervous System Disorders |
|
| Respiratory, Thoracic, and Mediastinal Disorders |
|