Trial Outcomes & Findings for DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) (NCT NCT04014075)
NCT ID: NCT04014075
Last Updated: 2025-04-03
Results Overview
The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on 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. Confirmed ORR based on ICR is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Up to 16 months (data cut-off)
Results posted on
2025-04-03
Participant Flow
A total of 79 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at clinic centers in United States, Spain, Italy, United Kingdom, and Belgium.
Participant milestones
| Measure |
Trastuzumab Deruxtecan
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
Trastuzumab Deruxtecan
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Overall Study
Progressive Disease
|
53
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Clinical Progression
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Miscellaneous
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
Baseline characteristics by cohort
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 16 months (data cut-off)Population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on 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. Confirmed ORR based on ICR is reported.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
38.0 Percentage of Participants
Interval 27.3 to 49.6
|
PRIMARY outcome
Timeframe: Up to 23 months (data cut-off)Population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021.
The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on 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. Confirmed ORR based on ICR is reported.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
41.8 Percentage of Participants
Interval 30.8 to 53.4
|
SECONDARY outcome
Timeframe: Up to 16 months (data cut-off)Population: Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
5.5 months
Interval 4.2 to 7.3
|
SECONDARY outcome
Timeframe: Up to 23 months (data cut-off)Population: Progression-free survival (PFS) was assessed in the Full Analysis Set data at cut-off date of 08 Nov 2021
Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
5.6 months
Interval 4.2 to 8.3
|
SECONDARY outcome
Timeframe: Up to 16 months (data cut-off)Population: Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Progression-Free Survival (PFS) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
5.5 months
Interval 4.1 to 6.9
|
SECONDARY outcome
Timeframe: Up to 16 months (data cut-off)Population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on 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. Confirmed ORR based on investigator assessment is reported.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
34.2 Percentage of Participants
Interval 23.9 to 45.7
|
SECONDARY outcome
Timeframe: Up to 23 months (data cut-off)Population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021.
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on 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. Confirmed ORR based on investigator assessment is reported.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
36.7 Percentage of Participants
Interval 26.1 to 48.3
|
SECONDARY outcome
Timeframe: Up to 16 months (data cut-off)Population: Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
NA months
Interval 11.5 to
Median OS and upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of OS events.
|
SECONDARY outcome
Timeframe: Up to 23 months (data cut-off)Population: Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021.
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
12.1 months
Interval 9.4 to 15.4
|
SECONDARY outcome
Timeframe: Up to 16 months (data cut-off)Population: Duration of Response (DOR) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
8.1 months
Interval 4.1 to
The upper limit was not estimable due to the reason that the curve representing the upper confidence limits for the survivor function lies above 0.5.
|
SECONDARY outcome
Timeframe: Up to 23 months (data cut-off)Population: Duration of Response (DOR) was assessed in the Full Analysis Set at data cut-off date of 08 Nov 2021.
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review.
Outcome measures
| Measure |
Trastuzumab Deruxtecan
n=79 Participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
|
8.1 months
Interval 5.9 to
The upper limit was not estimable due to the reason that the curve representing the upper confidence limits for the survivor function lies above 0.5.
|
Adverse Events
Trastuzumab Deruxtecan
Serious events: 37 serious events
Other events: 79 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Trastuzumab Deruxtecan
n=79 participants at risk
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Infections and infestations
Covid-19
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Bacterial Sepsis
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Covid-19 Pneumonia
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Device Related Infection
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Staphylococcal Infection
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Wound Infection
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis Carcinomatosa
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Basal Ganglia Infarction
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Generalised Tonic-Clonic Seizure
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
3/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Enteritis
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Disease Progression
|
2.5%
2/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Hyperpyrexia
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Exposure To Communicable Disease
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Product Issues
Device Occlusion
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Catheter Site Infection
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.1%
4/79 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Pyrexia
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.3%
1/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
Other adverse events
| Measure |
Trastuzumab Deruxtecan
n=79 participants at risk
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
|
|---|---|
|
Infections and infestations
Covid-19
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Device Related Infection
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
38.0%
30/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.1%
8/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
32.9%
26/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.5%
13/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.1%
8/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.6%
6/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Psychiatric disorders
Depression
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Headache
|
8.9%
7/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
7.6%
6/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Vascular disorders
Hypotension
|
7.6%
6/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.9%
7/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
9/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.1%
8/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
64.6%
51/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
44.3%
35/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.7%
29/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
29.1%
23/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.9%
11/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
10.1%
8/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Ascites
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.1%
19/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.9%
7/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Urinary Retention
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Fatigue
|
41.8%
33/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Asthenia
|
15.2%
12/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Weight Decreased
|
35.4%
28/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Platelet Count Decreased
|
17.7%
14/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Neutrophil Count Decreased
|
16.5%
13/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.5%
13/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
White Blood Cell Count Decreased
|
11.4%
9/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
10.1%
8/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
11.4%
9/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Blood Bilirubin Increased
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Oedema Peripheral
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Mucosal Inflammation
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Weight Increased
|
6.3%
5/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Blood Creatinine Increased
|
5.1%
4/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Pyrexia
|
12.7%
10/79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
Additional Information
Contact for Clinical Trial Information
Daiichi Sankyo
Phone: 1-908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place