Trial Outcomes & Findings for A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects (NCT NCT03776240)
NCT ID: NCT03776240
Last Updated: 2026-07-07
Results Overview
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin. Samples were collected from 0-1272 hours on Days 1-54.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
105 participants
Primary outcome timeframe
Up to day 54
Results posted on
2026-07-07
Participant Flow
A total of 105 evaluable subjects were planned to be randomly assigned to 3 treatment groups in a 1:1:1 ratio to receive a single i.v. infusion of 6 mg/kg of either HD201, EU-Herceptin, or US-Herceptin.
Participant milestones
| Measure |
HD201
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
US-licensed Herceptin
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
Reasons for withdrawal
| Measure |
HD201
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
US-licensed Herceptin
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
Baseline Characteristics
This study was conducted in healthy male volunteers only.
Baseline characteristics by cohort
| Measure |
HD201
n=35 Participants
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
n=35 Participants
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
US-licensed Herceptin
n=35 Participants
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.5 Years
n=20 Participants
|
29.6 Years
n=20 Participants
|
29.7 Years
n=40 Participants
|
28.9 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants • This study was conducted in healthy male volunteers only.
|
0 Participants
n=20 Participants • This study was conducted in healthy male volunteers only.
|
0 Participants
n=40 Participants • This study was conducted in healthy male volunteers only.
|
0 Participants
n=5 Participants • This study was conducted in healthy male volunteers only.
|
|
Sex: Female, Male
Male
|
35 Participants
n=20 Participants • This study was conducted in healthy male volunteers only.
|
35 Participants
n=20 Participants • This study was conducted in healthy male volunteers only.
|
35 Participants
n=40 Participants • This study was conducted in healthy male volunteers only.
|
105 Participants
n=5 Participants • This study was conducted in healthy male volunteers only.
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to day 54Population: The Pharmacokinetic Parameter (PKP) Population includes all subjects of the PKC Population who received a complete dose of study drug within the maximum prescribed time (i.e. 3 hours ± 10 minutes) and for whom the PK profile can be adequately characterized. Four subjects of the PKC Population were excluded from the PKP population as it was judged by the PK Analyst that the PK profile could not be adequately characterized because 2 or more consecutive samples were missed at the end.
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin. Samples were collected from 0-1272 hours on Days 1-54.
Outcome measures
| Measure |
US-licensed Herceptin
n=31 Participants
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
HD201
n=32 Participants
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
n=34 Participants
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
|---|---|---|---|
|
Trastuzumab Serum PK Parameter (AUC0-inf)
|
37298.5 h*μg/mL
Geometric Coefficient of Variation 15.5
|
38350.2 h*μg/mL
Geometric Coefficient of Variation 16.0
|
37432.7 h*μg/mL
Geometric Coefficient of Variation 16.7
|
PRIMARY outcome
Timeframe: Up to Day 54Population: The Pharmacokinetic Parameter (PKP) Population includes all subjects of the PKC Population who received a complete dose of study drug within the maximum prescribed time (i.e. 3 hours ± 10 minutes) and for whom the PK profile can be adequately characterized. Four subjects of the PKC Population were excluded from the PKP population as it was judged by the PK Analyst that the PK profile could not be adequately characterized because 2 or more consecutive samples were missed at the end.
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
Outcome measures
| Measure |
US-licensed Herceptin
n=31 Participants
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
HD201
n=32 Participants
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
n=34 Participants
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
|---|---|---|---|
|
Trastuzumab Serum PK Parameter (AUC0-last)
|
35619.9 h*μg/mL
Geometric Coefficient of Variation 15.3
|
36587.5 h*μg/mL
Geometric Coefficient of Variation 17.6
|
35337.1 h*μg/mL
Geometric Coefficient of Variation 17.0
|
PRIMARY outcome
Timeframe: Up to Day 54Population: The Pharmacokinetic Parameter (PKP) Population includes all subjects of the PKC Population who received a complete dose of study drug within the maximum prescribed time (i.e. 3 hours ± 10 minutes) and for whom the PK profile can be adequately characterized. Four subjects of the PKC Population were excluded from the PKP population as it was judged by the PK Analyst that the PK profile could not be adequately characterized because 2 or more consecutive samples were missed at the end.
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
Outcome measures
| Measure |
US-licensed Herceptin
n=31 Participants
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
HD201
n=32 Participants
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
n=34 Participants
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
|---|---|---|---|
|
Trastuzumab Serum PK Parameter (Cmax)
|
151.10 μg/mL
Geometric Coefficient of Variation 16.6
|
148.86 μg/mL
Geometric Coefficient of Variation 19.5
|
142.28 μg/mL
Geometric Coefficient of Variation 15.5
|
Adverse Events
HD201
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
EU-licensed Herceptin
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
US-licensed Herceptin
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HD201
n=35 participants at risk
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
n=35 participants at risk
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
US-licensed Herceptin
n=35 participants at risk
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • Number of events 1 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
Other adverse events
| Measure |
HD201
n=35 participants at risk
Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
EU-licensed Herceptin
n=35 participants at risk
EU-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
US-licensed Herceptin
n=35 participants at risk
US-Herceptin Single-dose 6mg/kg body weight by 90 minute intravenous infusion
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
31.4%
11/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
22.9%
8/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
20.0%
7/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.4%
4/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
20.0%
7/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
31.4%
11/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
14.3%
5/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
11.4%
4/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Chest pain
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Pyrexia
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
8.6%
3/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Influenza like illness
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
11.4%
4/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.6%
3/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
8.6%
3/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
5.7%
2/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
11.4%
4/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
2.9%
1/35 • All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place