Trial Outcomes & Findings for A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations (NCT NCT03691207)
NCT ID: NCT03691207
Last Updated: 2024-01-31
Results Overview
ORR is defined as partial response (PR) + complete response (CR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
3 years and 7 months
Results posted on
2024-01-31
Participant Flow
Participant milestones
| Measure |
Cohort 1 - AL101 4mg
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
AL101 6 mg once weekly (QW) intravenously (IV)
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
42
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
45
|
42
|
Reasons for withdrawal
| Measure |
Cohort 1 - AL101 4mg
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
AL101 6 mg once weekly (QW) intravenously (IV)
|
|---|---|---|
|
Overall Study
Death
|
41
|
26
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
8
|
|
Overall Study
Sponsor decision
|
1
|
7
|
Baseline Characteristics
A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Baseline characteristics by cohort
| Measure |
Cohort 1 - AL101 4mg
n=45 Participants
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
n=42 Participants
AL101 6 mg once weekly (QW) intravenously (IV)
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Continuous
|
50 Years
n=99 Participants
|
59 Years
n=107 Participants
|
56 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
23 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
France
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 years and 7 monthsPopulation: Efficacy evaluable analysis set includes all subjects who receive at least one complete infusion of study drug, have measurable disease at baseline per RECIST v1.1 or modified MDA criteria for bone-exclusive disease and have at least one post-baseline on-study assessment of tumor response.
ORR is defined as partial response (PR) + complete response (CR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cohort 1 - AL101 4mg
n=41 Participants
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
n=36 Participants
AL101 6 mg once weekly (QW) intravenously (IV)
|
|---|---|---|
|
Overall Response Rate (ORR)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 years and 7 monthsPopulation: Efficacy evaluable analysis set includes all subjects who receive at least one complete infusion of study drug, have measurable disease at baseline per RECIST v1.1 or modified MDA criteria for bone-exclusive disease and have at least one post-baseline on-study assessment of tumor response.
Clinical benefit response rate (CBR) is defined as complete response (CR) + partial response (PR) + stable disease (SD) by investigator review based on RECIST v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage (at least 30%) to qualify for PR nor sufficient increase (more than 20%) to qualify for PD, taking as reference the smallest sum diameters.
Outcome measures
| Measure |
Cohort 1 - AL101 4mg
n=41 Participants
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
n=36 Participants
AL101 6 mg once weekly (QW) intravenously (IV)
|
|---|---|---|
|
Clinical Benefit Response Rate (CBR)
|
28 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 3 years and 5 monthsPopulation: Efficacy evaluable analysis set includes all subjects who receive at least one complete infusion of study drug, have measurable disease at baseline per RECIST v1.1 or modified MDA criteria for bone-exclusive disease and have at least one post-baseline on-study assessment of tumor response.
Overall survival is defined at the time from first infusion of investigational product to death due to any cause. Subjects with no documentation of death were censored at the last known date known to be alive.
Outcome measures
| Measure |
Cohort 1 - AL101 4mg
n=41 Participants
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
n=36 Participants
AL101 6 mg once weekly (QW) intravenously (IV)
|
|---|---|---|
|
Overall Survival
|
9.3 months
Interval 6.6 to 14.2
|
9.4 months
Interval 5.9 to 11.9
|
Adverse Events
Cohort 1 - AL101 4mg
Serious events: 23 serious events
Other events: 45 other events
Deaths: 41 deaths
Cohort 2 - AL101 6mg
Serious events: 26 serious events
Other events: 42 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Cohort 1 - AL101 4mg
n=45 participants at risk
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
n=42 participants at risk
AL101 6 mg mg once weekly (QW) intravenously (IV)
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
4.8%
2/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Sepsis
|
4.4%
2/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Clostridium difficile colitis
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Abdominal abscess
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Appendicitis
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Brain abscess
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Campylobacter sepsis
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Cellulitis
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Cellulitis orbital
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Meningitis bacterial
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Skin infection
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Staphylococcal infection
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
4.8%
2/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Ileus
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Haemorrhage intracranial
|
4.4%
2/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Transient ischaemic attack
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.4%
2/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
4.8%
2/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Blood and lymphatic system disorders
Bone marrow infiltration
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Fatigue
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Renal and urinary disorders
Renal impairment
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Vascular disorders
Vasculitis
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
Other adverse events
| Measure |
Cohort 1 - AL101 4mg
n=45 participants at risk
AL101 4 mg once weekly (QW) intravenously (IV)
|
Cohort 2 - AL101 6mg
n=42 participants at risk
AL101 6 mg mg once weekly (QW) intravenously (IV)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
68.9%
31/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
78.6%
33/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Nausea
|
66.7%
30/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
45.2%
19/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Vomiting
|
46.7%
21/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
31.0%
13/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Constipation
|
22.2%
10/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
23.8%
10/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Dry mouth
|
15.6%
7/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
31.0%
13/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
16.7%
7/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
5/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
5/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.4%
2/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.7%
21/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
38.1%
16/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.1%
14/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
33.3%
14/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.8%
8/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
19.0%
8/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
17.8%
8/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
11.9%
5/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.6%
7/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
11.9%
5/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.4%
2/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
4.8%
2/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Fatigue
|
66.7%
30/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
59.5%
25/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Asthenia
|
4.4%
2/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
16.7%
7/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Mucosal inflammation
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
11.9%
5/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Pyrexia
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Chills
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Oedema peripheral
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Facial pain
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
General disorders
Swelling face
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
55.6%
25/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
42.9%
18/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
10/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
28.6%
12/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.8%
8/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
14.3%
6/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
11.9%
5/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
2/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
5/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
9/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
16.7%
7/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.8%
8/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
19.0%
8/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
9/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
16.7%
7/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.8%
8/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
16.7%
7/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
19.0%
8/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.6%
7/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
11.9%
5/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
13.3%
6/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
4.8%
2/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Headache
|
28.9%
13/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Dysgeusia
|
15.6%
7/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
21.4%
9/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Dizziness
|
13.3%
6/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Nervous system disorders
Taste disorder
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Pneumonia
|
13.3%
6/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Urinary tract infection
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Rash pustular
|
11.1%
5/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Oral candidiasis
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Candida infection
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Investigations
Weight decreased
|
15.6%
7/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
26.2%
11/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
5/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Investigations
Platelet count decreased
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Investigations
Neutrophil count increased
|
0.00%
0/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.9%
13/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
2.4%
1/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
4/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Psychiatric disorders
Insomnia
|
22.2%
10/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
28.6%
12/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Psychiatric disorders
Anxiety
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
4.8%
2/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Psychiatric disorders
Depression
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
4.8%
2/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Eye disorders
Vision blurred
|
17.8%
8/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Eye disorders
Dry eye
|
2.2%
1/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Eye disorders
Photophobia
|
6.7%
3/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
0.00%
0/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Vascular disorders
Hypertension
|
15.6%
7/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
5/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
7.1%
3/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
|
Blood and lymphatic system disorders
Anaemia
|
15.6%
7/45 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
9.5%
4/42 • 3 years and 7 months
The analysis was done on the safety population which consists of 87 patients (45 patients in the 4mg arm, and 42 patients in the 6mg arm) Safety analysis set includes all subjects who receive at least one infusion of study drug, including partial infusions..
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place