Trial Outcomes & Findings for Zalutumumab in Head and Neck Cancer (NCT NCT00093041)
NCT ID: NCT00093041
Last Updated: 2023-06-28
Results Overview
Number of participants reporting at least one adverse event.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From study start (Day 0) until follow-up period (up to Day 77)
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Zalutumumab 0.15 mg/kg
|
Zalutumumab 0.5 mg/kg
|
Zalutumumab 1 mg/kg
|
Zalutumumab 2 mg/kg
|
Zalutumumab 4 mg/kg
|
Zalutumumab 8 mg/kg
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
4
|
4
|
7
|
|
Overall Study
COMPLETED
|
2
|
1
|
3
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
1
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zalutumumab in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Zalutumumab 0.15 mg/kg
n=4 Participants
|
Zalutumumab 0.5 mg/kg
n=4 Participants
|
Zalutumumab 1 mg/kg
n=5 Participants
|
Zalutumumab 2 mg/kg
n=4 Participants
|
Zalutumumab 4 mg/kg
n=4 Participants
|
Zalutumumab 8 mg/kg
n=7 Participants
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
59 years
n=7 Participants
|
57 years
n=5 Participants
|
55 years
n=4 Participants
|
53 years
n=21 Participants
|
58 years
n=8 Participants
|
57 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=8 Participants
|
23 participants
n=8 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
5 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From study start (Day 0) until follow-up period (up to Day 77)Population: Number of participants reporting at least one adverse event
Number of participants reporting at least one adverse event.
Outcome measures
| Measure |
Zalatumumab 0.15 mg/kg
n=4 Participants
|
Zalutumumab 0.5 mg/kg
n=4 Participants
|
Zalutumumab 1 mg/kg
n=5 Participants
|
Zalutumumab 2 mg/kg
n=4 Participants
|
Zalutumumab 4 mg/kg
n=4 Participants
|
Zalutumumab 8 mg/kg
n=7 Participants
|
|---|---|---|---|---|---|---|
|
Adverse Events
|
4 participants
|
4 participants
|
5 participants
|
4 participants
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 8 weeksBest Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Outcome measures
| Measure |
Zalatumumab 0.15 mg/kg
n=4 Participants
|
Zalutumumab 0.5 mg/kg
n=4 Participants
|
Zalutumumab 1 mg/kg
n=5 Participants
|
Zalutumumab 2 mg/kg
n=4 Participants
|
Zalutumumab 4 mg/kg
n=4 Participants
|
Zalutumumab 8 mg/kg
n=7 Participants
|
|---|---|---|---|---|---|---|
|
Overall Response (OR), Classification
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Response (OR), Classification
Progression
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Overall Response (OR), Classification
Missing
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Overall Response (OR), Classification
Partial Response
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Overall Response (OR), Classification
Stable Disease
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
3 participants
|
3 participants
|
Adverse Events
Zalutumumab 0.15 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Zalutumumab 0.5 mg/kg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Zalutumumab 1 mg/kg
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Zalutumumab 2 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Zalutumumab 4 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Zalutumumab 8 mg/kg
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zalutumumab 0.15 mg/kg
n=4 participants at risk
|
Zalutumumab 0.5 mg/kg
n=4 participants at risk
|
Zalutumumab 1 mg/kg
n=5 participants at risk
|
Zalutumumab 2 mg/kg
n=4 participants at risk
|
Zalutumumab 4 mg/kg
n=4 participants at risk
|
Zalutumumab 8 mg/kg
n=7 participants at risk
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Bleeding from tumour
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
40.0%
2/5 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Administration site condition
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Infections and infestations
Syncope vasovagal
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
Other adverse events
| Measure |
Zalutumumab 0.15 mg/kg
n=4 participants at risk
|
Zalutumumab 0.5 mg/kg
n=4 participants at risk
|
Zalutumumab 1 mg/kg
n=5 participants at risk
|
Zalutumumab 2 mg/kg
n=4 participants at risk
|
Zalutumumab 4 mg/kg
n=4 participants at risk
|
Zalutumumab 8 mg/kg
n=7 participants at risk
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
40.0%
2/5 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
75.0%
3/4 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
100.0%
4/4 • Number of events 5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
71.4%
5/7 • Number of events 6 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
60.0%
3/5 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
71.4%
5/7 • Number of events 6 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
50.0%
2/4 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
57.1%
4/7 • Number of events 6 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
50.0%
2/4 • Number of events 4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
28.6%
2/7 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
60.0%
3/5 • Number of events 4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
28.6%
2/7 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
50.0%
2/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
40.0%
2/5 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
28.6%
2/7 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
75.0%
3/4 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
28.6%
2/7 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Rigors
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
57.1%
4/7 • Number of events 5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Sweating increased
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
40.0%
2/5 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
40.0%
2/5 • Number of events 4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Flushing
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 2 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 3 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Influenza like
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/5 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
25.0%
1/4 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Oedema
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
14.3%
1/7 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
|
General disorders
Asthenia
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
20.0%
1/5 • Number of events 1 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/4 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
0.00%
0/7 • From study start (Day 0) until end of follow-up period (up to Day 77)
|
Additional Information
VP Clinical Operations Eva Järlid Westerberg
Genmab A/S
Phone: +45 7020 2728
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place