Trial Outcomes & Findings for Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer (NCT NCT03366428)
NCT ID: NCT03366428
Last Updated: 2022-04-12
Results Overview
The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)
Results posted on
2022-04-12
Participant Flow
A total of 51 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at 7 sites in Japan.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Progressive disease per RECIST v1.1
|
33
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Clinical progression
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
Baseline characteristics by cohort
| Measure |
DS-8201a
n=51 Participants
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.
|
|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
|
Age, Customized
<65
|
38 Participants
n=5 Participants
|
|
Age, Customized
≥65
|
13 Participants
n=5 Participants
|
|
Age, Customized
>75
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)Population: QTc and QTcF were assessed in the Cardiac Analysis Set.
The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.
Outcome measures
| Measure |
DS-8201a
n=49 Participants
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.
|
HER2 Low
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Maximum change from baseline in QTcF: >30 ms
|
3 Participants
|
—
|
|
Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer
Maximum change from baseline in QTcF: >60 ms
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 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)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.
Outcome measures
| Measure |
DS-8201a
n=51 Participants
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.
|
HER2 Low
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
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
DS-8201: Cycle 1
|
179 ug/mL
Standard Deviation 112
|
—
|
|
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
DS-8201: Cycle 3
|
154 ug/mL
Standard Deviation 23.3
|
—
|
|
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
Total Anti-HER2 antibody: Cycle 1
|
165 ug/mL
Standard Deviation 110
|
—
|
|
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
Total Anti-HER2 antibody: Cycle 3
|
142 ug/mL
Standard Deviation 27.0
|
—
|
PRIMARY outcome
Timeframe: 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)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Maximum serum concentration (Cmax) of MAAA-1181 was assessed.
Outcome measures
| Measure |
DS-8201a
n=51 Participants
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.
|
HER2 Low
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
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
MAAA-1181a: Cycle 1
|
12.6 ng/mL
Standard Deviation 4.49
|
—
|
|
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
MAAA-1181a: Cycle 3
|
9.60 ng/mL
Standard Deviation 3.89
|
—
|
PRIMARY outcome
Timeframe: 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)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
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.
Outcome measures
| Measure |
DS-8201a
n=51 Participants
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.
|
HER2 Low
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
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
AUClast, DS-8201: Cycle 1
|
677 ug*d/mL
Standard Deviation 143
|
—
|
|
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
AUClast, Total Anti-HER2 antibody: Cycle 1
|
753 ug*d/mL
Standard Deviation 190
|
—
|
|
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
AUCtau, DS-8201: Cycle 1
|
677 ug*d/mL
Standard Deviation 141
|
—
|
|
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
AUCtau, DS-8201: Cycle 3
|
905 ug*d/mL
Standard Deviation 189
|
—
|
|
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
AUCtau, Total Anti-HER2 antibody: Cycle 1
|
752 ug*d/mL
Standard Deviation 185
|
—
|
|
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
AUCtau, Total Anti-HER2 antibody: Cycle 3
|
1030 ug*d/mL
Standard Deviation 256
|
—
|
PRIMARY outcome
Timeframe: 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)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Area under the concentration versus-time curve from time 0 to the last quantifiable concentration (AUClast) and during the dosing interval (AUCtau) were assessed.
Outcome measures
| Measure |
DS-8201a
n=51 Participants
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.
|
HER2 Low
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
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
AUClast, MAAA-1181a: Cycle 1
|
39.3 ng*d/mL
Standard Deviation 11.3
|
—
|
|
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
AUCtau, MAAA-1181a: Cycle 1
|
39.0 ng*d/mL
Standard Deviation 11.2
|
—
|
|
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
AUCtau, MAAA-1181a: Cycle 3
|
41.5 ng*d/mL
Standard Deviation 13.8
|
—
|
SECONDARY outcome
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 12 months post-dosePopulation: Response was assessed in the Efficacy Analysis Set.
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.
Outcome measures
| Measure |
DS-8201a
n=4 Participants
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.
|
HER2 Low
n=47 Participants
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
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
|
2 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 38 months post-dosePopulation: Response was assessed in the Efficacy Analysis Set.
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.
Outcome measures
| Measure |
DS-8201a
n=4 Participants
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.
|
HER2 Low
n=47 Participants
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
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
|
2 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to approximately 12 months post-dosePopulation: Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.
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.
Outcome measures
| Measure |
DS-8201a
n=51 Participants
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.
|
HER2 Low
Participants with HER2 low expression (defined as immunohistochemistry 1+ or 2+/ in situ hybridization negative or missing) 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.
|
|---|---|---|
|
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
Nervous System Disorders
|
15 Participants
|
—
|
|
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
Blood and Lymphatic System Disorders
|
30 Participants
|
—
|
|
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
Anaemia
|
30 Participants
|
—
|
|
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
Skin and Subcutaneous Tissue Disorders
|
27 Participants
|
—
|
|
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
Alopecia
|
21 Participants
|
—
|
|
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
General Disorders and Administration Site Conditions
|
25 Participants
|
—
|
|
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
Fatigue
|
11 Participants
|
—
|
|
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
Infections and Infestations
|
21 Participants
|
—
|
|
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
Nasopharyngitis
|
11 Participants
|
—
|
|
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
Metabolism and Nutrition Disorders
|
19 Participants
|
—
|
|
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
Decreased appetite
|
16 Participants
|
—
|
|
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
Respiratory, Thoracic, and Mediastinal Disorders
|
12 Participants
|
—
|
|
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
Any TEAEs
|
51 Participants
|
—
|
|
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
Gastrointestinal Disorders
|
45 Participants
|
—
|
|
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
Nausea
|
42 Participants
|
—
|
|
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
Vomiting
|
20 Participants
|
—
|
|
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
Constipation
|
16 Participants
|
—
|
|
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
Stomatitis
|
16 Participants
|
—
|
|
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
Diarrhoea
|
14 Participants
|
—
|
|
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
Investigations
|
45 Participants
|
—
|
|
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
Neutrophil count decreased
|
36 Participants
|
—
|
|
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
White blood cell count decreased
|
31 Participants
|
—
|
|
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
Platelet count decreased
|
20 Participants
|
—
|
|
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
Lymphocyte count decreased
|
13 Participants
|
—
|
|
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
Alanine aminotransferase increased
|
12 Participants
|
—
|
|
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
Aspartate aminotransferase increased
|
12 Participants
|
—
|
Adverse Events
DS-8201a
Serious events: 9 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS-8201a
n=51 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • 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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Cellulitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Lung infection
|
2.0%
1/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.0%
1/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/51 • 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.
|
Other adverse events
| Measure |
DS-8201a
n=51 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Nausea
|
82.4%
42/51 • 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.
|
|
Investigations
Neutrophil count decreased
|
70.6%
36/51 • 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.
|
|
Investigations
White blood cell count decreased
|
66.7%
34/51 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
62.7%
32/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
41.2%
21/51 • 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.
|
|
Investigations
Platelet count decreased
|
39.2%
20/51 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
41.2%
21/51 • 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.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
17/51 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
41.2%
21/51 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.4%
16/51 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
17/51 • 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.
|
|
Investigations
Lymphocyte count decreased
|
29.4%
15/51 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
27.5%
14/51 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
25.5%
13/51 • 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.
|
|
General disorders
Fatigue
|
21.6%
11/51 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
31.4%
16/51 • 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.
|
|
General disorders
Malaise
|
23.5%
12/51 • 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.
|
|
General disorders
Pyrexia
|
27.5%
14/51 • 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.
|
|
Nervous system disorders
Dysgeusia
|
13.7%
7/51 • 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.
|
|
Nervous system disorders
Headache
|
13.7%
7/51 • 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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.8%
5/51 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
5/51 • 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.
|
|
Investigations
Electrocardiogram QT prolonged
|
9.8%
5/51 • 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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.8%
6/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
5/51 • 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.
|
|
Psychiatric disorders
Anxiety
|
5.9%
3/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.8%
5/51 • 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.
|
|
Psychiatric disorders
Insomnia
|
9.8%
5/51 • 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.
|
|
Investigations
Weight decreased
|
9.8%
5/51 • 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.
|
|
Infections and infestations
Lung infection
|
7.8%
4/51 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
5/51 • 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.
|
|
Infections and infestations
Ginsivitis
|
5.9%
3/51 • 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.
|
|
Infections and infestations
Influenza
|
5.9%
3/51 • 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.
|
|
Infections and infestations
Gastroenteritis
|
3.9%
2/51 • 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.
|
|
Infections and infestations
Paronychia
|
3.9%
2/51 • 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.
|
|
Infections and infestations
Pharyngitis
|
3.9%
2/51 • 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.
|
|
Infections and infestations
Rhinitis
|
3.9%
2/51 • 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.
|
|
Infections and infestations
Angular cheilitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Cellulitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Cystitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Dacryocystitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Folliculitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Hordeolum
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Infection
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Laryngitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Periodontitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Skin infection
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Skin candida
|
2.0%
1/51 • 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.
|
|
Infections and infestations
Oral herpes
|
2.0%
1/51 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
2.0%
1/51 • 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.
|
|
Immune system disorders
Seasonal allergy
|
3.9%
2/51 • 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.
|
|
Immune system disorders
Allergy to arthropod sting
|
2.0%
1/51 • 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.
|
|
Immune system disorders
Contrast media allergy
|
2.0%
1/51 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.9%
2/51 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
1/51 • 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.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.0%
1/51 • 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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
1/51 • 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.
|
|
Psychiatric disorders
Agitation
|
2.0%
1/51 • 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.
|
|
Nervous system disorders
Dizziness
|
9.8%
5/51 • 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.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.9%
2/51 • 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.
|
|
Nervous system disorders
Akathisia
|
2.0%
1/51 • 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.
|
|
Nervous system disorders
Vagus nerve disorder
|
2.0%
1/51 • 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.
|
|
Nervous system disorders
Visual perseveration
|
2.0%
1/51 • 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.
|
|
Eye disorders
Conjunctivitis allergic
|
3.9%
2/51 • 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.
|
|
Eye disorders
Dry eye
|
3.9%
2/51 • 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.
|
|
Eye disorders
Punctate keratitis
|
3.9%
2/51 • 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.
|
|
Eye disorders
Blepharitis
|
2.0%
1/51 • 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.
|
|
Eye disorders
Cataract
|
2.0%
1/51 • 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.
|
|
Eye disorders
Chalazion
|
2.0%
1/51 • 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.
|
|
Eye disorders
Corneal disorder
|
2.0%
1/51 • 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.
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
1/51 • 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.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/51 • 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.
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • 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.
|
|
Vascular disorders
Embolism
|
2.0%
1/51 • 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.
|
|
Vascular disorders
Venous thrombosis limb
|
2.0%
1/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.7%
8/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.7%
7/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
9.8%
5/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.8%
5/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
3/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
3/51 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Periodontal disease
|
5.9%
3/51 • 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.
|
|
Gastrointestinal disorders
Proctalgia
|
5.9%
3/51 • 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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.9%
2/51 • 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.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
3.9%
2/51 • 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.
|
|
Gastrointestinal disorders
Faeces soft
|
3.9%
2/51 • 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.
|
|
Gastrointestinal disorders
Anal fissure
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Food poisoning
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
2.0%
1/51 • 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.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/51 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
9.8%
5/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
4/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
3/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
1/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
2.0%
1/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
2.0%
1/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.0%
1/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.0%
1/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
2.0%
1/51 • 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.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
2.0%
1/51 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
4/51 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
3/51 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.9%
2/51 • 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.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/51 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/51 • 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.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.0%
1/51 • 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.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.0%
1/51 • 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.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.0%
1/51 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
1/51 • 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.
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.0%
1/51 • 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.
|
|
Reproductive system and breast disorders
Uterine polyp
|
2.0%
1/51 • 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.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
2.0%
1/51 • 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.
|
|
General disorders
Oedema
|
5.9%
3/51 • 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.
|
|
General disorders
Oedema peripheral
|
5.9%
3/51 • 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.
|
|
General disorders
Chest pain
|
3.9%
2/51 • 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.
|
|
General disorders
Withdrawal syndrome
|
2.0%
1/51 • 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.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/51 • 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.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.8%
5/51 • 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.
|
|
Investigations
Blood bilirubin increased
|
7.8%
4/51 • 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.
|
|
Investigations
Blood creatinine increased
|
3.9%
2/51 • 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.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.9%
2/51 • 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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.9%
2/51 • 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.
|
|
Investigations
Protein total decreased
|
3.9%
2/51 • 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.
|
|
Investigations
Blood urea increased
|
2.0%
1/51 • 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.
|
|
Investigations
Weight increased
|
2.0%
1/51 • 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.
|
|
Investigations
Ejection fraction decreased
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Bite
|
2.0%
1/51 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/51 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place